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Biotech Stock Roundup: GILD Down on Study Results, INBX Gains on Sanofi Deal & More
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Merger updates and other regulatory news were in focus in the biotech sector ahead of the fourth-quarter results. While nothing came from other bigwigs, Gilead Sciences (GILD - Free Report) shares took a hit on disappointing results from a late-stage study.
Recap of the Week’s Most Important Stories:
Gilead Tanks on Study Failure: Shares of Gilead Sciences declined after it announced that the late-stage study evaluating oncology drug Trodelvy (sacituzumab govitecan) in previously treated metastatic non-small cell lung cancer (NSCLC) failed.
The phase III study, EVOKE-01, evaluated Trodelvy vis-à-vis docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. The study enrolled 603 participants who were randomized equally in both arms.
The study did not meet its primary endpoint of overall survival (OS), even though a numerical improvement in OS favoring sacituzumab govitecan was observed in the study in patients with both squamous and non-squamous histology. Data further showed a difference of more than three months in median OS favoring sacituzumab govitecan in a sub-group of patients non-responsive to the last prior anti-PD-(L)1 therapy.
These patients represented more than 60% of the trial population. This analysis was pre-specified in the protocol but not alpha-controlled for formal statistical testing. However, this magnitude of difference was not observed in the sub-group of patients with response to the last prior anti-PD-(L)1 therapy. Trodelvy's performance has been outstanding since its approval, and the drug is driving Gilead's efforts to build a strong oncology franchise, especially given the current focus on ADCs. The results of the EVOKE-01 study in the lucrative NSCLC indication were a setback and disappointed investors. NSCLC is the most common form of lung cancer.
Patent Ruling for Exelixis: Exelixis (EXEL - Free Report) announced that it has successfully defended an EU patent for lead drug Cabometyx (cabozantinib) tablets against three opponents in a hearing before the Opposition Division of the European Patent Office (EPO). The three opponents were STADA Arzneimittel AG, Teva Pharmaceuticals and Generics (U.K.) Ltd.
The Opposition Division panel (comprising three members) rejected all grounds of conflict, thus upholding EXEL’s patent for Cabometyx as granted. The patent has an expiration date of Jul 18, 2031, and covers tablet formulations of cabozantinib. This includes the tablet formulation approved for various oncology indications as Cabometyx tablets by the European Medicines Agency. Per Exelixis, the EPO’s ruling is specific to the European patent at issue and is subject to appeal.
Exelixis and partner Bristol Myers also announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo (nivolumab) in combination with Cabometyx versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). Results continued to show superior progression-free survival and objective response rates in patients treated with the combination therapy over sunitinib, regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium scores. Superior overall survival was also observed in patients treated with the combination.
Inhibrx Up on Sanofi Deal: Inhibrx (INBX - Free Report) gained after it announced a definite agreement with Sanofi (SNY - Free Report) , which will acquire its pipeline candidate, INBRX-101, for an aggregate transaction value of nearly $2.2 billion. INBRX-101, an optimized, recombinant alpha-1 antitrypsin (AAT) augmentation therapy, is currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency (AATD).
Per the terms of the agreement, Sanofi will initially acquire all outstanding shares of Inhibrx through a merger. Post this merger, Sanofi will retain the AATD candidate and will spin out all the other pipeline programs acquired from Inhibrx into a new publicly traded company, Inhibrx Biosciences, Inc., which will continue to be operated by INBX’s current management.
Existing Inhibrx shareholders will be eligible to receive $30 per share in cash as consideration for entering into the merger. The existing shareholders will also receive one non-tradeable contingent value right (CVR) per share, entitling the holder to receive an additional $5 per share, provided a regulatory milestone is achieved. For every share of Inhibrx held, existing shareholders will be eligible to receive 0.25 shares of New Inhibrx.
Post this distribution, existing Inhibrx shareholders will hold a 92% stake in New Inhibrx, while Sanofi will retain the remaining 8%. Sanofi will also pay off all of Inhibrx’s currently outstanding third-party debt and capitalize on the newly formed company with $200 million in cash.
Performance
The Nasdaq Biotechnology Index has gained 0.17% in the past five trading sessions. Among the biotech giants, Biogen has gained 2.23% during the period. Over the past six months, shares of Amgen have surged 33.75%. (See the last biotech stock roundup here: Biotech Stock Roundup: VRTX/CRSP Gene Therapy Label Expansion, ALLK Falls on Update)
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What's Next in Biotech?
Stay tuned for more pipeline updates.
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Biotech Stock Roundup: GILD Down on Study Results, INBX Gains on Sanofi Deal & More
Merger updates and other regulatory news were in focus in the biotech sector ahead of the fourth-quarter results. While nothing came from other bigwigs, Gilead Sciences (GILD - Free Report) shares took a hit on disappointing results from a late-stage study.
Recap of the Week’s Most Important Stories:
Gilead Tanks on Study Failure: Shares of Gilead Sciences declined after it announced that the late-stage study evaluating oncology drug Trodelvy (sacituzumab govitecan) in previously treated metastatic non-small cell lung cancer (NSCLC) failed.
The phase III study, EVOKE-01, evaluated Trodelvy vis-à-vis docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. The study enrolled 603 participants who were randomized equally in both arms.
The study did not meet its primary endpoint of overall survival (OS), even though a numerical improvement in OS favoring sacituzumab govitecan was observed in the study in patients with both squamous and non-squamous histology. Data further showed a difference of more than three months in median OS favoring sacituzumab govitecan in a sub-group of patients non-responsive to the last prior anti-PD-(L)1 therapy.
These patients represented more than 60% of the trial population. This analysis was pre-specified in the protocol but not alpha-controlled for formal statistical testing. However, this magnitude of difference was not observed in the sub-group of patients with response to the last prior anti-PD-(L)1 therapy.
Trodelvy's performance has been outstanding since its approval, and the drug is driving Gilead's efforts to build a strong oncology franchise, especially given the current focus on ADCs. The results of the EVOKE-01 study in the lucrative NSCLC indication were a setback and disappointed investors. NSCLC is the most common form of lung cancer.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Patent Ruling for Exelixis: Exelixis (EXEL - Free Report) announced that it has successfully defended an EU patent for lead drug Cabometyx (cabozantinib) tablets against three opponents in a hearing before the Opposition Division of the European Patent Office (EPO). The three opponents were STADA Arzneimittel AG, Teva Pharmaceuticals and Generics (U.K.) Ltd.
The Opposition Division panel (comprising three members) rejected all grounds of conflict, thus upholding EXEL’s patent for Cabometyx as granted. The patent has an expiration date of Jul 18, 2031, and covers tablet formulations of cabozantinib. This includes the tablet formulation approved for various oncology indications as Cabometyx tablets by the European Medicines Agency. Per Exelixis, the EPO’s ruling is specific to the European patent at issue and is subject to appeal.
Exelixis and partner Bristol Myers also announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo (nivolumab) in combination with Cabometyx versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). Results continued to show superior progression-free survival and objective response rates in patients treated with the combination therapy over sunitinib, regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium scores. Superior overall survival was also observed in patients treated with the combination.
Inhibrx Up on Sanofi Deal: Inhibrx (INBX - Free Report) gained after it announced a definite agreement with Sanofi (SNY - Free Report) , which will acquire its pipeline candidate, INBRX-101, for an aggregate transaction value of nearly $2.2 billion. INBRX-101, an optimized, recombinant alpha-1 antitrypsin (AAT) augmentation therapy, is currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency (AATD).
Per the terms of the agreement, Sanofi will initially acquire all outstanding shares of Inhibrx through a merger. Post this merger, Sanofi will retain the AATD candidate and will spin out all the other pipeline programs acquired from Inhibrx into a new publicly traded company, Inhibrx Biosciences, Inc., which will continue to be operated by INBX’s current management.
Existing Inhibrx shareholders will be eligible to receive $30 per share in cash as consideration for entering into the merger. The existing shareholders will also receive one non-tradeable contingent value right (CVR) per share, entitling the holder to receive an additional $5 per share, provided a regulatory milestone is achieved. For every share of Inhibrx held, existing shareholders will be eligible to receive 0.25 shares of New Inhibrx.
Post this distribution, existing Inhibrx shareholders will hold a 92% stake in New Inhibrx, while Sanofi will retain the remaining 8%. Sanofi will also pay off all of Inhibrx’s currently outstanding third-party debt and capitalize on the newly formed company with $200 million in cash.
Performance
The Nasdaq Biotechnology Index has gained 0.17% in the past five trading sessions. Among the biotech giants, Biogen has gained 2.23% during the period. Over the past six months, shares of Amgen have surged 33.75%. (See the last biotech stock roundup here: Biotech Stock Roundup: VRTX/CRSP Gene Therapy Label Expansion, ALLK Falls on Update)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.