It was a busy week for the biotech sector with Biogen BIIB kick-starting the second-quarter earnings season. Meanwhile, pipeline updates from quite a few companies were also a key area of focus in the sector. Celgene CELG obtained FDA approval for the label expansion of Otezla, while Vertex VRTX submitted its NDA for a triple combination to treat cystic fibrosis.
Recap of the Week’s Top Stories:
Biogen Fires on All Cylinders in Q2: Biogen reported second-quarter 2019 results, wherein it easily beat earnings and sales expectations. Revenue growth was principally driven by higher sales of key multiple sclerosis (MS) drug, Tecfidera, globally and spinal muscular atrophy (SMA) drug, Spinraza, in the United States. Backed by a strong second quarter, the company raised its annual guidance for revenues and earnings per share, and lowered the same for costs and tax expenses.
Vertex Submits NDA for Triple Combination Regime: Vertex Pharmaceuticals Incorporated submitted a New Drug Application (NDA) to the FDA for its triple combination regimen — VX-445 (elexacaftor), tezacaftor and ivacaftor — for cystic fibrosis. The NDA includes a request for Priority Review, which will shorten the FDA’s review period to eight months from the date of submission versus the standard review timeline of 12 months from submission. The NDA was supported by previously disclosed positive results of two global phase III studies — a 24-week phase III study in patients with one F508del mutation and one minimal function mutation, and a 4-week phase III study in patients with two F508del mutations.
Vertex currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene Gets FDA Nod for Label Expansion of Otezla, Updates Collaboration With Jounce: Celgene announced that the FDA has approved Otezla for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. The approval was based on positive results from the RELIEF study, wherein Otezla reduced the number and pain of oral ulcers in the 12-week placebo-controlled phase III study. Notably, the drug is already approved for two additional indications in the United States —for the treatment of patients with moderate-to-severe plaque psoriasis, who are candidates for phototherapy or systemic therapy, and adult patients with active psoriatic arthritis. Hence, the drug is now approved for three indications in the United States. The drug is also under review in Japan (regulatory decision is expected in the second half of 2019) and Europe for this indication.
Meanwhile, Celgene also updated its collaboration with Jounce Therapeutics JNCE, following which shares of the latter surged. The original collaboration was announced in July 2016. Under the terms of a new agreement, Celgene has licensed worldwide rights to JTX-8064, a highly-selective, potential first-in-class antibody that targets the LILRB2 receptor on macrophages, to Jounce. Jounce will retain full worldwide rights to its pipeline beyond JTX-8064, including vopratelimab, JTX-4014 and all discovery programs. Both companies have also entered a mutual agreement to terminate their original collaboration agreement.
Gilead Licenses Research Programs From Novartis, Provides Other Updates: Gilead Sciences GILD licensed three preclinical antiviral programs from Novartis, including investigational agents for the treatment of human rhinovirus, influenza and herpes viruses. Per the terms, the company will acquire exclusive global rights to develop and commercialize novel small molecules against three undisclosed targets. In exchange, Novartis will receive an upfront payment and an additional $291 million as milestone payments.
Gilead also announced data from two phase III trials — one demonstrating the effectiveness of switching to Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) from other regimens in women, and another evaluating the potential for the single-tablet regimen to be an effective treatment option in virologically suppressed patients with known resistance to nucleo(s)tide or non-nucleo(s)tide reverse transcriptase inhibitors. At week 96, 99.5% of women, who received Biktarvy throughout the study duration, and 98.5% of women, who switched to Biktarvy at week 48, maintained virologic suppression with no development of treatment-emergent resistance.
FDA Cancels Meeting for Intra-Cellular’s Schizophrenia Treatment: Intra-Cellular Therapies, Inc. ITCI announced that the FDA has cancelled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for Jul 31, 2019, to discuss its NDA for lumateperone for the treatment of schizophrenia. The company recently provided additional information to the FDA in response to information requests related to non-clinical studies. The FDA cancelled the meeting to get sufficient time to review this and any forthcoming information, as it continues the NDA review. Consequently, the Prescription Drug User Fee Act (PDUFA) target action date of Sep 27, 2019, for the same might be extended.
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index lost 0.20% in the last five trading sessions. Among the major biotech giants, Regeneron lost 3.65% in the period. Over the past six months, shares of Celgene have gained 2.89%, whereas the Biogen stock has declined 26.55%. (See the last biotech stock roundup here: Biotech Stock Roundup: Galapagos & Hookipa Surge, AMGN Shelves Alzheimer’s Study)
What's Next in Biotech?
Stay tuned for earnings updates and other pipeline news.
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