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[8-K] Rhythm Pharmaceuticals, Inc. Reports Material Event

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

Biotechnology Value Fund and affiliated entities have filed a Schedule 13G disclosing a collective 7.4% passive stake in Nektar Therapeutics (NASDAQ: NKTR). The filing, dated 9 July 2025 with an event date of 1 July 2025, reports aggregate beneficial ownership of 1,276,595 common shares out of 17,301,061 shares outstanding following the company’s recent public offering.

The ownership is spread across multiple Delaware and Cayman-based vehicles: Biotechnology Value Fund (LP) holds 661,758 shares (3.8%), Biotechnology Value Fund II (LP) holds 517,813 shares (3.0%), and Biotechnology Value Trading Fund OS (LP) holds 71,367 shares (<1%). Control is exercised jointly through the general partners BVF GP Holdings LLC and BVF Partners L.P., with Mark N. Lampert signing on behalf of each entity. All shares are held with shared voting and dispositive power; none of the reporting persons claims sole authority.

The filing is made on Form 13G—indicating a passive investment intent rather than an activist position� and includes the customary certification that the securities were not acquired to influence control of the issuer. No other material transactions, derivatives, or lock-up arrangements are disclosed.

Key take-aways for investors: BVF’s aggregated 7.4% stake makes it one of the largest outside shareholders of Nektar, signalling confidence from a specialist biotech investor group. However, because the filing is passive, immediate governance or strategic changes should not be expected.

Biotechnology Value Fund e entità affiliate hanno presentato un modulo Schedule 13G, rivelando una partecipazione passiva collettiva del 7,4% in Nektar Therapeutics (NASDAQ: NKTR). La comunicazione, datata 9 luglio 2025 con data evento 1 luglio 2025, riporta una proprietà beneficiaria aggregata di 1.276.595 azioni ordinarie su 17.301.061 azioni in circolazione dopo la recente offerta pubblica della società.

La proprietà è distribuita tra diversi veicoli basati in Delaware e Cayman: Biotechnology Value Fund (LP) detiene 661.758 azioni (3,8%), Biotechnology Value Fund II (LP) detiene 517.813 azioni (3,0%) e Biotechnology Value Trading Fund OS (LP) detiene 71.367 azioni (<1%). Il controllo è esercitato congiuntamente tramite i general partner BVF GP Holdings LLC e BVF Partners L.P., con Mark N. Lampert che firma per ciascuna entità. Tutte le azioni sono detenute con potere di voto e disposizione condivisi; nessuno dei soggetti segnalanti rivendica autorità esclusiva.

La comunicazione è stata effettuata tramite il modulo 13G � che indica un intento di investimento passivo e non una posizione attivista � e include la consueta certificazione che i titoli non sono stati acquisiti per influenzare il controllo dell’emittente. Non sono state divulgate altre transazioni rilevanti, derivati o accordi di lock-up.

Punti chiave per gli investitori: la partecipazione aggregata del 7,4% di BVF la rende uno dei maggiori azionisti esterni di Nektar, segnalando fiducia da parte di un gruppo specializzato di investitori biotech. Tuttavia, poiché la comunicazione è passiva, non sono da aspettarsi cambiamenti immediati nella governance o nella strategia.

Biotechnology Value Fund y entidades afiliadas han presentado un Schedule 13G revelando una participación pasiva colectiva del 7,4% en Nektar Therapeutics (NASDAQ: NKTR). La presentación, fechada el 9 de julio de 2025 con fecha del evento 1 de julio de 2025, reporta una propiedad beneficiaria agregada de 1.276.595 acciones comunes de un total de 17.301.061 acciones en circulación tras la reciente oferta pública de la compañía.

La propiedad está distribuida entre varios vehículos con base en Delaware y las Islas Caimán: Biotechnology Value Fund (LP) posee 661.758 acciones (3,8%), Biotechnology Value Fund II (LP) posee 517.813 acciones (3,0%) y Biotechnology Value Trading Fund OS (LP) posee 71.367 acciones (<1%). El control se ejerce conjuntamente a través de los socios generales BVF GP Holdings LLC y BVF Partners L.P., con Mark N. Lampert firmando en nombre de cada entidad. Todas las acciones se mantienen con poder de voto y disposición compartidos; ninguno de los informantes reclama autoridad exclusiva.

La presentación se realiza mediante el Formulario 13G � lo que indica una intención de inversión pasiva en lugar de una posición activista � e incluye la certificación habitual de que los valores no fueron adquiridos para influir en el control del emisor. No se divulgan otras transacciones materiales, derivados o acuerdos de bloqueo.

Puntos clave para los inversores: la participación agregada del 7,4% de BVF la convierte en uno de los mayores accionistas externos de Nektar, señalando confianza por parte de un grupo especializado de inversores en biotecnología. Sin embargo, dado que la presentación es pasiva, no se esperan cambios inmediatos en la gobernanza o en la estrategia.

Biotechnology Value Fund � 관� 기관들이 Nektar Therapeutics (NASDAQ: NKTR)� 대� 7.4%� 수동� 지분을 공개하는 Schedule 13G� 제출했습니다. 2025� 7� 9일자 제출서류(이벤� 날짜 2025� 7� 1�)� 따르�, 최근 회사� 공개 발행 이후 � 17,301,061� � 1,276,595�� 보통주를 집합적으� 보유하고 있습니다.

지분은 델라웨어 � 케이맨 소재 여러 투자 수단� 분산되어 있습니다: Biotechnology Value Fund (LP)� 661,758�(3.8%), Biotechnology Value Fund II (LP)� 517,813�(3.0%), Biotechnology Value Trading Fund OS (LP)� 71,367�(<1%)� 보유하고 있습니다. 지배력은 BVF GP Holdings LLC와 BVF Partners L.P.라는 일반 파트너를 통해 공동으로 행사되며, � 기관� 대표해 Mark N. Lampert가 서명했습니다. 모든 주식은 공동 의결� � 처분 권한으로 보유되며, 보고� � 어느 누구� 단독 권한� 주장하지 않습니다.

� 제출은 Form 13G� 이루어졌으며, 이는 수동� 투자 의도� 나타내며 행동주의� 입장� 아님� 의미합니�. 또한, 증권� 발행사의 지배권� 영향� 미치� 위해 취득� 것이 아님� 인증하는 내용� 포함되어 있습니다. 기타 중요� 거래, 파생상품 또는 락업 계약은 공개되지 않았습니�.

투자자를 위한 주요 시사�: BVF� 7.4% 집합 지분은 Nektar� 주요 외부 주주 � 하나임을 나타내며, 전문 바이오텍 투자� 그룹� 신뢰� 반영합니�. 다만, 제출� 수동적이므� 즉각적인 거버넌스 또는 전략� 변화는 기대하지 않아� 합니�.

Biotechnology Value Fund et entités affiliées ont déposé un Schedule 13G révélant une participation passive collective de 7,4 % dans Nektar Therapeutics (NASDAQ : NKTR). Le dépôt, daté du 9 juillet 2025 avec une date d’événement au 1er juillet 2025, rapporte une propriété bénéficiaire agrégée de 1 276 595 actions ordinaires sur 17 301 061 actions en circulation suite à la récente offre publique de la société.

La propriété est répartie entre plusieurs véhicules basés dans le Delaware et aux îles Caïmans : Biotechnology Value Fund (LP) détient 661 758 actions (3,8 %), Biotechnology Value Fund II (LP) détient 517 813 actions (3,0 %) et Biotechnology Value Trading Fund OS (LP) détient 71 367 actions (<1 %). Le contrôle est exercé conjointement par les partenaires généraux BVF GP Holdings LLC et BVF Partners L.P., avec Mark N. Lampert signant au nom de chaque entité. Toutes les actions sont détenues avec pouvoirs de vote et de disposition partagés ; aucun des déclarants ne revendique une autorité exclusive.

Le dépôt est effectué via le formulaire 13G � indiquant une intention d’investissement passive plutôt qu’une position activiste � et inclut la certification habituelle que les titres n’ont pas été acquis pour influencer le contrôle de l’émetteur. Aucune autre transaction importante, dérivés ou accords de blocage ne sont divulgués.

Points clés pour les investisseurs : la participation agrégée de 7,4 % de BVF en fait l’un des plus grands actionnaires externes de Nektar, signalant la confiance d’un groupe d’investisseurs spécialisés en biotechnologie. Cependant, puisque le dépôt est passif, aucun changement immédiat de gouvernance ou de stratégie n’est à prévoir.

Biotechnology Value Fund und verbundene Einheiten haben ein Schedule 13G eingereicht, das eine kollektive passive Beteiligung von 7,4 % an Nektar Therapeutics (NASDAQ: NKTR) offenlegt. Die Einreichung vom 9. Juli 2025 mit Ereignisdatum 1. Juli 2025 berichtet über den aggregierten wirtschaftlichen Eigentum von 1.276.595 Stammaktien von insgesamt 17.301.061 ausstehenden Aktien nach dem jüngsten öffentlichen Angebot des Unternehmens.

Das Eigentum verteilt sich auf mehrere in Delaware und auf den Cayman Islands ansässige Vehikel: Biotechnology Value Fund (LP) hält 661.758 Aktien (3,8 %), Biotechnology Value Fund II (LP) hält 517.813 Aktien (3,0 %) und Biotechnology Value Trading Fund OS (LP) hält 71.367 Aktien (<1 %). Die Kontrolle wird gemeinsam durch die General Partner BVF GP Holdings LLC und BVF Partners L.P. ausgeübt, wobei Mark N. Lampert im Namen jeder Einheit unterschreibt. Alle Aktien werden mit gemeinsamem Stimm- und Verfügungsrecht gehalten; keiner der meldenden Personen beansprucht alleinige Befugnis.

Die Einreichung erfolgt mittels Formular 13G � was auf eine passive Anlageabsicht und keine aktivistische Position hinweist � und enthält die übliche Bestätigung, dass die Wertpapiere nicht zum Zweck der Einflussnahme auf die Kontrolle des Emittenten erworben wurden. Es werden keine weiteren wesentlichen Transaktionen, Derivate oder Sperrvereinbarungen offengelegt.

Wichtige Erkenntnisse für Investoren: Die aggregierte Beteiligung von 7,4 % von BVF macht sie zu einem der größten externen Aktionäre von Nektar, was Vertrauen seitens einer spezialisierten Biotech-Investorengruppe signalisiert. Da die Einreichung jedoch passiv ist, sind keine unmittelbaren Änderungen in der Unternehmensführung oder Strategie zu erwarten.

Positive
  • Specialist biotech investor BVF now owns 7.4% of NKTR, adding reputable institutional support.
  • Filing is on Schedule 13G, confirming the stake is passive and reducing near-term governance risk.
Negative
  • None.

Insights

TL;DR � BVF reveals 7.4% passive stake, signalling specialist confidence but no activist intentions.

The 13G shows BVF entities accumulating 1.28 million NKTR shares after the company’s July 2025 equity offering. At 7.4% of outstanding, BVF becomes a significant holder yet stays below the 10% insider threshold and files a passive 13G rather than 13D. For investors, a biotech-focused fund’s sizable position can bolster market sentiment and provide validation of Nektar’s pipeline value. Nevertheless, the passive designation limits expectations for near-term governance influence or catalyst-driven activism. Impact is moderately positive because increased institutional ownership can improve liquidity and support the share price, but there is no direct operational effect.

Biotechnology Value Fund e entità affiliate hanno presentato un modulo Schedule 13G, rivelando una partecipazione passiva collettiva del 7,4% in Nektar Therapeutics (NASDAQ: NKTR). La comunicazione, datata 9 luglio 2025 con data evento 1 luglio 2025, riporta una proprietà beneficiaria aggregata di 1.276.595 azioni ordinarie su 17.301.061 azioni in circolazione dopo la recente offerta pubblica della società.

La proprietà è distribuita tra diversi veicoli basati in Delaware e Cayman: Biotechnology Value Fund (LP) detiene 661.758 azioni (3,8%), Biotechnology Value Fund II (LP) detiene 517.813 azioni (3,0%) e Biotechnology Value Trading Fund OS (LP) detiene 71.367 azioni (<1%). Il controllo è esercitato congiuntamente tramite i general partner BVF GP Holdings LLC e BVF Partners L.P., con Mark N. Lampert che firma per ciascuna entità. Tutte le azioni sono detenute con potere di voto e disposizione condivisi; nessuno dei soggetti segnalanti rivendica autorità esclusiva.

La comunicazione è stata effettuata tramite il modulo 13G � che indica un intento di investimento passivo e non una posizione attivista � e include la consueta certificazione che i titoli non sono stati acquisiti per influenzare il controllo dell’emittente. Non sono state divulgate altre transazioni rilevanti, derivati o accordi di lock-up.

Punti chiave per gli investitori: la partecipazione aggregata del 7,4% di BVF la rende uno dei maggiori azionisti esterni di Nektar, segnalando fiducia da parte di un gruppo specializzato di investitori biotech. Tuttavia, poiché la comunicazione è passiva, non sono da aspettarsi cambiamenti immediati nella governance o nella strategia.

Biotechnology Value Fund y entidades afiliadas han presentado un Schedule 13G revelando una participación pasiva colectiva del 7,4% en Nektar Therapeutics (NASDAQ: NKTR). La presentación, fechada el 9 de julio de 2025 con fecha del evento 1 de julio de 2025, reporta una propiedad beneficiaria agregada de 1.276.595 acciones comunes de un total de 17.301.061 acciones en circulación tras la reciente oferta pública de la compañía.

La propiedad está distribuida entre varios vehículos con base en Delaware y las Islas Caimán: Biotechnology Value Fund (LP) posee 661.758 acciones (3,8%), Biotechnology Value Fund II (LP) posee 517.813 acciones (3,0%) y Biotechnology Value Trading Fund OS (LP) posee 71.367 acciones (<1%). El control se ejerce conjuntamente a través de los socios generales BVF GP Holdings LLC y BVF Partners L.P., con Mark N. Lampert firmando en nombre de cada entidad. Todas las acciones se mantienen con poder de voto y disposición compartidos; ninguno de los informantes reclama autoridad exclusiva.

La presentación se realiza mediante el Formulario 13G � lo que indica una intención de inversión pasiva en lugar de una posición activista � e incluye la certificación habitual de que los valores no fueron adquiridos para influir en el control del emisor. No se divulgan otras transacciones materiales, derivados o acuerdos de bloqueo.

Puntos clave para los inversores: la participación agregada del 7,4% de BVF la convierte en uno de los mayores accionistas externos de Nektar, señalando confianza por parte de un grupo especializado de inversores en biotecnología. Sin embargo, dado que la presentación es pasiva, no se esperan cambios inmediatos en la gobernanza o en la estrategia.

Biotechnology Value Fund � 관� 기관들이 Nektar Therapeutics (NASDAQ: NKTR)� 대� 7.4%� 수동� 지분을 공개하는 Schedule 13G� 제출했습니다. 2025� 7� 9일자 제출서류(이벤� 날짜 2025� 7� 1�)� 따르�, 최근 회사� 공개 발행 이후 � 17,301,061� � 1,276,595�� 보통주를 집합적으� 보유하고 있습니다.

지분은 델라웨어 � 케이맨 소재 여러 투자 수단� 분산되어 있습니다: Biotechnology Value Fund (LP)� 661,758�(3.8%), Biotechnology Value Fund II (LP)� 517,813�(3.0%), Biotechnology Value Trading Fund OS (LP)� 71,367�(<1%)� 보유하고 있습니다. 지배력은 BVF GP Holdings LLC와 BVF Partners L.P.라는 일반 파트너를 통해 공동으로 행사되며, � 기관� 대표해 Mark N. Lampert가 서명했습니다. 모든 주식은 공동 의결� � 처분 권한으로 보유되며, 보고� � 어느 누구� 단독 권한� 주장하지 않습니다.

� 제출은 Form 13G� 이루어졌으며, 이는 수동� 투자 의도� 나타내며 행동주의� 입장� 아님� 의미합니�. 또한, 증권� 발행사의 지배권� 영향� 미치� 위해 취득� 것이 아님� 인증하는 내용� 포함되어 있습니다. 기타 중요� 거래, 파생상품 또는 락업 계약은 공개되지 않았습니�.

투자자를 위한 주요 시사�: BVF� 7.4% 집합 지분은 Nektar� 주요 외부 주주 � 하나임을 나타내며, 전문 바이오텍 투자� 그룹� 신뢰� 반영합니�. 다만, 제출� 수동적이므� 즉각적인 거버넌스 또는 전략� 변화는 기대하지 않아� 합니�.

Biotechnology Value Fund et entités affiliées ont déposé un Schedule 13G révélant une participation passive collective de 7,4 % dans Nektar Therapeutics (NASDAQ : NKTR). Le dépôt, daté du 9 juillet 2025 avec une date d’événement au 1er juillet 2025, rapporte une propriété bénéficiaire agrégée de 1 276 595 actions ordinaires sur 17 301 061 actions en circulation suite à la récente offre publique de la société.

La propriété est répartie entre plusieurs véhicules basés dans le Delaware et aux îles Caïmans : Biotechnology Value Fund (LP) détient 661 758 actions (3,8 %), Biotechnology Value Fund II (LP) détient 517 813 actions (3,0 %) et Biotechnology Value Trading Fund OS (LP) détient 71 367 actions (<1 %). Le contrôle est exercé conjointement par les partenaires généraux BVF GP Holdings LLC et BVF Partners L.P., avec Mark N. Lampert signant au nom de chaque entité. Toutes les actions sont détenues avec pouvoirs de vote et de disposition partagés ; aucun des déclarants ne revendique une autorité exclusive.

Le dépôt est effectué via le formulaire 13G � indiquant une intention d’investissement passive plutôt qu’une position activiste � et inclut la certification habituelle que les titres n’ont pas été acquis pour influencer le contrôle de l’émetteur. Aucune autre transaction importante, dérivés ou accords de blocage ne sont divulgués.

Points clés pour les investisseurs : la participation agrégée de 7,4 % de BVF en fait l’un des plus grands actionnaires externes de Nektar, signalant la confiance d’un groupe d’investisseurs spécialisés en biotechnologie. Cependant, puisque le dépôt est passif, aucun changement immédiat de gouvernance ou de stratégie n’est à prévoir.

Biotechnology Value Fund und verbundene Einheiten haben ein Schedule 13G eingereicht, das eine kollektive passive Beteiligung von 7,4 % an Nektar Therapeutics (NASDAQ: NKTR) offenlegt. Die Einreichung vom 9. Juli 2025 mit Ereignisdatum 1. Juli 2025 berichtet über den aggregierten wirtschaftlichen Eigentum von 1.276.595 Stammaktien von insgesamt 17.301.061 ausstehenden Aktien nach dem jüngsten öffentlichen Angebot des Unternehmens.

Das Eigentum verteilt sich auf mehrere in Delaware und auf den Cayman Islands ansässige Vehikel: Biotechnology Value Fund (LP) hält 661.758 Aktien (3,8 %), Biotechnology Value Fund II (LP) hält 517.813 Aktien (3,0 %) und Biotechnology Value Trading Fund OS (LP) hält 71.367 Aktien (<1 %). Die Kontrolle wird gemeinsam durch die General Partner BVF GP Holdings LLC und BVF Partners L.P. ausgeübt, wobei Mark N. Lampert im Namen jeder Einheit unterschreibt. Alle Aktien werden mit gemeinsamem Stimm- und Verfügungsrecht gehalten; keiner der meldenden Personen beansprucht alleinige Befugnis.

Die Einreichung erfolgt mittels Formular 13G � was auf eine passive Anlageabsicht und keine aktivistische Position hinweist � und enthält die übliche Bestätigung, dass die Wertpapiere nicht zum Zweck der Einflussnahme auf die Kontrolle des Emittenten erworben wurden. Es werden keine weiteren wesentlichen Transaktionen, Derivate oder Sperrvereinbarungen offengelegt.

Wichtige Erkenntnisse für Investoren: Die aggregierte Beteiligung von 7,4 % von BVF macht sie zu einem der größten externen Aktionäre von Nektar, was Vertrauen seitens einer spezialisierten Biotech-Investorengruppe signalisiert. Da die Einreichung jedoch passiv ist, sind keine unmittelbaren Änderungen in der Unternehmensführung oder Strategie zu erwarten.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 9, 2025

 

RHYTHM PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-38223   46-2159271
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification Number)

 

222 Berkeley Street

12th Floor

Boston, MA 02116

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (857) 264-4280

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share RYTM The Nasdaq Stock Market LLC (Nasdaq Global Market)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

On July 9, 2025, Rhythm Pharmaceuticals, Inc. (“Rhythm”) issued a press release and published a corporate presentation announcing topline results from its Phase 2 trial evaluating bivamelagon (formerly LB54640), an investigational oral melanocortin-4 receptor (“MC4R”) agonist, in patients with acquired hypothalamic obesity, which are summarized under Item 8.01 below. The presentation is available in the “Events & Presentations” portion of the Company's website at ir.rhythmtx.com. A copy of the press release and presentation are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.

 

The information contained in Item 7.01 of this Current Report (including Exhibits 99.1 and 99.2 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly provided by specific reference in such a filing.

 

 

Item 8.01. Other Events.

 

On July 9, 2025, Rhythm announced topline results from its Phase 2 clinical trial evaluating bivamelagon (formerly LB54640), an investigational oral MC4R agonist, in patients with acquired hypothalamic obesity, which are summarized below.

 

Bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (“BMI”) at 14 weeks of treatment, consistent with BMI reductions achieved with setmelanotide therapy in similar patient populations in past trials. Rhythm in-licensed bivamelagon from LG Chem, Ltd in January 2024.

 

In the 14-week, double-blind, four-arm, placebo-controlled portion of the trial, bivamelagon achieved:

 

  ·   -9.3% BMI reduction from baseline in the 600mg cohort (n=8) (p-value=0.0004);
  ·   -7.7% BMI reduction from baseline in the 400mg cohort (n=7) (p-value=0.0002);
  ·   -2.7% BMI reduction from baseline in the 200mg cohort (n=6) (p-value=0.0180); and
  ·   BMI for patients in the placebo cohort (n=7) increased by 2.2% over 14 weeks.

 

In a post-hoc analysis comparing the randomized Phase 2 results to results from prior setmelanotide trials, bivamelagon demonstrated BMI reductions consistent with BMI reductions achieved with setmelanotide therapy as observed in similar patient populations at comparable dosing durations. In this post-hoc comparison of the subset of setmelanotide patients who demonstrated study compliance and were not on concomitant GLP1 therapy (no patients who enrolled in the Phase 2 bivamelagon trial were on concomitant GLP1 therapy), setmelanotide and bivamelagon achieved:

 

  ·   -9.7% and -10.1% mean BMI reductions achieved in a pooled patient population (n=59; n=64) from Phase 2 and Phase 3 trials of setmelanotide therapy at 12 weeks and 16 weeks, respectively; as compared to:
  ·  

-8.8% and -10.1% mean BMI reductions achieved in patients (400mg n=6; 600mg n=7) at 14 weeks of bivamelagon therapy.

 

In addition, patients reported meaningful reductions in their ‘most’ hunger scores at 14 weeks on therapy compared to placebo, consistent with past setmelanotide trials and MC4R agonism. Patients in the 600mg (n=8) and 400mg (n=6) cohorts achieved a mean reduction greater than 2.8 points in their ‘most’ hunger scores measured on a 10-point scale at 14 weeks of bivamelagon therapy. Six patients in the 200mg arm achieved a mean reduction of 2.1 points in their ‘most’ hunger score, while patients on placebo therapy reported a mean increase of 0.8 points in their mean ‘most’ hunger score.

 

 

 

 

Bivamelagon demonstrated safety and tolerability results consistent with MC4R agonism and mechanism of action during the placebo-controlled portion of the trial. During the placebo-controlled portion of the trial, one patient discontinued therapy due to a serious adverse event (rectal bleeding). The most common reported adverse events were episodes of diarrhea and nausea, the vast majority of which were mild or grade 1. There were reports of mild, localized hyperpigmentation from four patients, including one patient on placebo. A total of 27 patients completed the 14-week, placebo-controlled portion of the trial, and 26 of them transitioned into the open-label extension of the trial and remained in that portion of the trial, as of July 7, 2025. The reported adverse events were as follows:

 

n (%)   Bivamelagon
200mg
(N=6)
    Bivamelagon
400mg
(N=7)
    Bivamelagon
600mg
(N=8)
    Placebo
(N=7)
 
Any Adverse Events (“AEs”)     6 (100)       7 (100)       8 (100)       6 (86)  
Serious AEs     0 (0)       1 (14)       0       1 (14)  
Treatment-Related AEs     6 (100)       7 (100)       8 (100)       3 (43)  
Treatment-Related Serious Adverse Events     0       1 (14)       0       0  
Grade ≥3 AE     0       2 (29)       0       1 (14)  
AEs Leading to Study Intervention Discontinuation     0       1 (14)*     0       0  
AEs with >=10% in all Bivamelagon dosing (N=21)                                
Nausea     6 (100)       5 (71)       4 (50)       2 (29)  
Diarrhea     2 (33)       5 (71)       3 (37)       1 (14)  
Vomiting     2 (33)       4 (57)       4 (50)       2 (29)  
Headache     1 (17)       5 (71)       0 (0)     2 (29)  
AEs of Special Interest     2 (33)       3 (43)     0       0  
Skin Pigmentation**     2 (29)       2 (29)       0       0  
Adrenal Adverse Events             1 (14)       0       0  

 

* Rectal bleeding.

** In addition to the four patients on study drug, one placebo-treated participant had skin hyperpigmentation that was not treatment related and therefore not included as an AE of special interest. 

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

The following Exhibits 99.1 and 99.2 shall be deemed to be furnished and not filed.

 

Exhibit

No.

  Description
99.1   Press release dated July 9, 2025
99.2   Presentation dated July 9, 2025
104   Cover Page Interactive Data File (embedded within the inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  RHYTHM PHARMACEUTICALS, INC.
     
Date: July 9, 2024 By: /s/ Hunter Smith
    Hunter Smith
    Chief Financial Officer

 

 

 

FAQ

How many Nektar Therapeutics (NKTR) shares does Biotechnology Value Fund own?

The BVF entities collectively beneficially own 1,276,595 NKTR common shares.

What percentage of NKTR’s outstanding shares does BVF’s stake represent?

The filing states BVF’s aggregate stake equals 7.4% of the 17,301,061 shares outstanding as of 2 July 2025.

Is BVF’s filing activist or passive?

It is a Schedule 13G, indicating a passive investment with no intent to influence control.

Who signed the Schedule 13G on behalf of the BVF entities?

Mark N. Lampert signed as Authorized Signatory for all reporting persons.

Which BVF entities individually hold more than 5% of NKTR?

BVF GP Holdings LLC is deemed to hold 6.8%; Partners, BVF Inc. and Mr. Lampert each may be deemed to hold 7.4%.
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Biotechnology
Pharmaceutical Preparations
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