News

It was a busy week for the biotech sector, with numerous study readouts and other updates. Quite a few companies offered important updates on their key candidates. While nothing much came from biotech bigwigs, collaborations with pharma bigwigs and other news were in focus.

Recap of the Week’s Most Important Stories:

Voyager Gains From Novartis Deal: Voyager Therapeutics, Inc. VYGR announced a strategic collaboration and capsid license agreement with Novartis Pharma AG, a subsidiary of pharma giant Novartis NVS. Voyager aims to discover and develop new approaches for Huntington’s disease (HD) and spinal muscular atrophy (SMA) through this agreement with Novartis.

Voyager will provide Novartis with a target-exclusive license to access its TRACER capsids and other intellectual property for the respective diseases. Both companies will collaborate to advance a preclinical gene therapy candidate for HD.

Per the financial terms, Novartis will make an upfront payment of $100 million to Voyager, including a $20 million purchase of newly issued equity in Voyager. Voyager is also eligible to receive up to $1.2 billion in preclinical, development, regulatory and sales milestones, as well as tiered royalties on global net sales of products that incorporate its TRACER capsids. In lieu, Novartis will obtain target-exclusive access to Voyager’s TRACER capsids related to SMA for the duration of the agreement and will be responsible for all development and commercialization activities.

Novartis will also receive worldwide rights to Voyager’s adeno-associated virus gene therapy for HD, leveraging VYGR’s TRACER capsids and proprietary payloads. While Voyager will be responsible for preclinical advancement, Novartis will be responsible for all clinical development and commercialization of the HD program. Shares of Voyager jumped on the deal announcement.

Voyager currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

CORT Down on Litigation: Corcept Therapeutics Incorporated CORT tumbled after the U.S. district court of New Jersey passed its judgment on the company’s patent infringement lawsuit against Teva Pharmaceuticals. The lawsuit was related to Corcept’s sole marketed drug, Korlym (mifepristone), which is approved for treating Cushing’s syndrome. The court ruled in favor of Teva as Corcept did not meet its burden of proof and failed to demonstrate the likelihood of direct infringement of its patent by Teva.

Teva has been looking to market and sell a generic version of Korlym prior to the expiration of patents related to the drug. Teva has already filed an abbreviated new drug application (ANDA), No. 211436, to the FDA seeking approval for its generic version of Korlym. Following this, Corcept initiated the abovementioned lawsuit, alleging patent infringement and seeking a permanent injunction to restrict TEVA from launching its generic version of Korlym. In August 2020, Teva received the FDA approval for its ANDA in accordance with the Hatch-Waxman Act.

Agios Up on Study Results: Shares of Agios Pharmaceuticals, Inc. AGIO gained 5.2% after the company announced that the late-stage ENERGIZE study was successful. The study is evaluating mitapivat in adults with non-transfusion-dependent (NTD) alpha- or beta-thalassemia. The phase III study achieved its primary endpoint of hemoglobin response as mitapivat demonstrated a statistically significant increase in hemoglobin response rate compared to placebo. Of patients in the mitapivat arm, 42.3% achieved a hemoglobin response compared to 1.6% of patients in the placebo arm.

Treatment with mitapivat also demonstrated statistically significant improvement compared to placebo for both key secondary endpoints - change from baseline in average FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale score from week 12 to week 24 and change from baseline in average hemoglobin concentration from week 12 to week 24. Agios plans to present a more detailed analysis of the phase III ENERGIZE data at an upcoming medical meeting.

Regulatory Update From BMY: Bristol Myers Squibb BMY announced that the European Medicines Agency has validated its marketing authorization application (MAA) for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib. The MAA is seeking approval of the candidate for the treatment of ROS1 TKI-naïve and pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors.

The MAA was based on positive results from the registrational phase I/II TRIDENT-1 trial (adult patients with ROS1-positiveNSCLCor NTRK-positive solid tumors) and CARE study (pediatric patients with NTRK-positive solid tumors). Data from these studies showed robust responses and durability in these patients. The FDA approved repotrectinib as an oral therapy for NSCLC under the brand name Augtyro in November 2023.

Performance

The Nasdaq Biotechnology Index has gained 0.05% in the past four trading sessions. Among the biotech giants, Moderna has gained 7.79% during the period. Over the past six months, shares of Regeneron have plunged 27.78%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMYs KRTX and RYZB Acquisition, CYTK Surges on Study Data).

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What's Next in Biotech?

Stay tuned for more pipeline updates.

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