This week, a few biotech companies came up with pipeline and regulatory updates. Incyte (INCY - Free Report) suffered a setback with its pipeline candidate and consequently, shares fell. Meanwhile, Apellis (APLS - Free Report) and aTyr Pharma (LIFE - Free Report) soared on positive pipeline updates.
Recap of the Week’s Most Important Stories:
Pipeline Update From Incyte: Incyte announced disappointing results from a late-stage study on pipeline candidate itacitinib (INCB039110), a novel and selective JAK1 inhibitor.
The phase III randomized, double-blind, placebo-controlled GRAVITAS-301 study was evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve (first-line) acute graft-versus-host disease (GVHD). The primary endpoint was overall response rate (ORR) at day 28, defined as the proportion of subjects demonstrating a complete response, very good partial response, or partial response. The key secondary endpoint is non-relapse mortality (NRM) at month 6, defined as the proportion of subjects who died due to causes other than malignancy relapse.
However, the study did not meet the primary endpoint of ORR improvement at day 28 compared to placebo plus corticosteroids (74.0% vs. 66.4%, p=0.08, respectively). While itacitinib added to corticosteroids improved the ORR in patients with treatment-naïve acute GVHD, the difference observed versus placebo plus corticosteroids was not statistically significant. Additionally, there was no difference observed in NRM at month 6 between the treatment and placebo arms.
Additionally, Incyte announced that its Marketing Authorization Application (MAA) for pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy has been validated by the European Medicines Agency (EMA).
Exelixis Expands Oncology Study: Exelixis, Inc. (EXEL - Free Report) announced that it plans to further expand the metastatic castration-resistant prostate cancer (CRPC) cohort of COSMIC-021, the phase Ib study of lead drug Cabometyx in combination with Tecentriq in patients with locally advanced or metastatic solid tumors, based on continued encouraging efficacy and safety data. The cohort, which was previously expanded from 30 to 80 patients in July 2019, will now include up to 130 patients. Exelixis expects the expansion of the cohort by an additional 50 patients to further document how the combination may benefit this patient population. The company is assessing its regulatory plans for the combination and preparing to initiate a phase III pivotal trial.
Exelixis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Apellis Soars on Encouraging PNH Study Results: Apellis Pharmaceuticals, Inc. surged after it announced positive results from the phase III PEGASUS study, evaluating pegcetacoplan (APL-2) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Pegcetacoplan met the study’s primary efficacy endpoint, demonstrating superiority to Soliris with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16 (p<0.0001). At week 16, pegcetacoplan-treated patients had an adjusted mean hemoglobin increase of 2.4 g/dL from a baseline of 8.7 g/dL compared to eculizumab-treated patients (n=39) who had a change of -1.5 g/dL from the baseline.
aTyr Surges on Collaboration Deal With Kyorin Pharma: aTyr Pharma surged more than 43% after it announced a collaboration and license agreement with Kyorin Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Kyorin Holdings, Inc.
Both companies have entered into a collaboration for the development and commercialization of aTyr’s lead candidate, ATYR1923, for interstitial lung diseases (ILDs) in Japan. Per the agreement, the company will receive an $8-million upfront payment and is eligible to receive up to an additional $167 million in milestone payments as well as tiered royalties on net sales in Japan. Kyorin, a leading respiratory focused pharmaceutical company in Japan, will receive the exclusive right to develop and commercialize ATYR1923 in Japan for ILDs and will be responsible for funding all research, development, regulatory, marketing and commercialization activities. Meanwhile, aTyr will supply all drug products for Japan and support development activities as the global development leader for ATYR1923.
The Nasdaq Biotechnology index lost 1.09% in the last four trading sessions. Among the biotech giants, Incyte lost 11.66% in the period. Over the past six months, shares of Amgen have gained 32.42%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMRN Stock Up, Pipeline Updates From GILD, BIIB, AMGN & More)
What's Next in Biotech?
Stay tuned for more pipeline updates.
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