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The NASDAQ Biotechnology Index  gained 2.6% in the trading session on Nov 25. This compares favorably with the NASDAQ Composite Index’s rise of 1.3%, S&P 500 Index’s 0.8% and Dow Jones Industrial Average’s 0.7% on the same day. Increasing M&A deals, growing AI dominance and favorable regulatory tidings continue to drive the biotech market. The sector has also been benefitting from a flurry of positive news, including trial results and deal activities. Let’s see what could have possible triggered the upside (read: Biotech ETFs in Focus on Impressive Q3 Earnings Results).

FDA Approval

The FDA approved Global Blood Therapeutics, Inc.’s GBT drug for treating sickle cell disease in adults and children aged 12 years or above on Nov 25. The shares of the company rose around 7% on the day. The drug will be marketed under the brand name of Oxbryta. With this development, the biotechnology sector has witnessed the approval of the second drug for treating sickle cell anaemia in recent days. Moreover, it has become the first drug to treat the primary cause of the disease instead of the symptoms. On Nov 15, Novartis AG NVS received FDA approval for Adakveo to bring down the frequency of vaso-occlusive crises or pain crises in adult and paediatric patients aged 16 years and older with sickle cell disease.

New Merger-Acquisition Deal

Swiss drugmaker Novartis AG recently announced plans to buy cholesterol drug developer, The Medicines Company, for $9.7 billion. The acquisition will give Novartis access to Medicines Co.’s near-to-market heart drug — inclisiran. Medicines Co. is expected to submit the drug to the FDA for approval by the end of 2019. The company has high chances of getting a clearance from the authorities as it recently presented positive data confirming the efficacy of the drug.

Release of Positive Data

CRISPR Therapeutics CRSP and its partner Vertex Pharmaceuticals Incorporated VRTX recently announced encouraging preliminary safety and efficacy data from the ongoing phase I/II studies. Notably, the studies are evaluating the CRISPR/Cas9 gene-editing therapy CTX001 for two severe blood disorders — sickle cell disease and adult transfusion-dependent b-thalassemia (TDT).

CRISPR Therapeutics and Vertex were each up 17% and 2.5%, respectively, on Nov 19, in response to the news. However, CRISPR lost some gains due to an underwritten public offering on the same day during after-hours trading (read: Genomics ETFs Surge on CRISPR's Gene Editing Progress).