BPC February 05 update

Tonix TNXP shares slump on trial termination; Biogen BIIB shares spike following patent win

Price and Volume Movers

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced it has stopped enrolment in its Phase 3 trial of Tonmya, for the treatment of posttraumatic stress disorder (PTSD), due to futility. The decision follows an interim analysis by the Independent Data Monitoring Committee (IDMC) which determined Tonmya is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in the severity of PTSD symptoms. Shares are currently trading down 67% to $0.56 after hours.

Merck (NYSE:MRK) announced its intention to spin-off products from its Women's Health, trusted Legacy Brands, and Biosimilars businesses into a new publicly traded company, leaving to focus on its oncology, vaccines, hospital and animal health arms of the business. Total revenue from the new company of approximately $6.5b in 2020 represents approximately 14% of total 2019 revenue for Merck. The company reported pharmaceutical sales revenue of $10.5b for the fourth quarter, an increase of 7% from the same quarter in 2018. Growth in oncology was largely driven by sales of Keytruda, which were $3.1b for the quarter, an increase of 45% on the same period in 2019.

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) shares closed up 15% to $19.98. The company announced its Investigational New Drug ("IND") application for its randomized, double-blind, placebo-controlled, Phase 1b/2 trial of BXCL501 for the treatment of opioid withdrawal symptoms, has received clearance from the FDA.

Biogen Inc. (NYSE: BIIB) shares closed up 18% to $332.87 following a successful defense from a patent challenge by generic company Mylan (NYSE: MYL). The Patent Trial and Appeal Board ruled in favor of Biogen in the challenge initiated by Mylan to invalidate its patent on its multiple sclerosis drug Tecfidera, which brought in revenues of $4.4b in 2019. The current patent lasts until 2028. Alkermes plc (NASDAQ: ALKS) shares also climbed in sympathy to the patent news, closing up 11% to $19.40. Alkermes received FDA approval in late-2019 for Vumerity, a follow-up of Tecfidera, which is licensed to Biogen.

Phio Pharmaceuticals Corp. (NASDAQ:PHIO) shares closed down 13% to $8.25. The company announced a registered direct offering of 197,056 shares at a price of $8.83 per share, for gross proceeds of approximately $1.74m.

Applied Genetic Technologies Corporation (NASDAQ:AGTC) announced after hours it has commenced an underwritten public offering of 6m shares of its common stock. Shares are trading down 11% after hours to $6.25.

Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM) announced a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-10 and will begin trading on a split-adjusted basis on February 6. Shares closed down 18% during the normal trading session, and are trading a further 8% to $1.10 after hours.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

VIVUS, Inc. (VVUS): $3.38; +47%.

Puma Biotechnology, Inc. (PBYI): $14.56; +38%.

Cyclerion Therapeutics, Inc. (CYCN): $4.26; +25%.

Aduro BioTech, Inc. (ADRO): $2.75; +23%.

Selecta Biosciences, Inc. (SELB): $4.41; +21%.

DECLINERS:

Rapt Therapeutics, Inc. (RAPT): $32.00; -24%.

aTyr Pharma, Inc. (LIFE): $4.51; -17%.

Ziopharm Oncology, Inc. (ZIOP): $3.40; -16%.

BioNTech SE (BNTX): $29.25; -11%.

Corvus Pharmaceuticals, Inc. (CRVS): $4.83; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Upadacitinib - SELECT-NEXT
Psoriatic arthritis

sNDA Filing Phase 3 primary endpoint met - February 5, 2020. sNDA filing due 2Q 2020.
$137.7 billion

BVXV – BiondVax Pharmaceuticals Ltd.
M-001
Universal flu vaccine

Phase 2 Phase 2 data due 2Q 2020.
$88.2 million

CHRS – Coherus BioSciences Inc.
Lucentis Biosimilar
Biosimilar

BLA Filing BLA submission withdrawn due to request for additional manufacturing data - February 5, 2020.
$1.5 billion

GNPX – Genprex Inc.
Oncoprex in combination with osimertinib
Non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1/2 trial to be initiated mid-2020.
$167.9 million

GSK – GlaxoSmithKline PLC
Benlysta (belimumab) and rituximab
Systemic lupus erythematosus (SLE)

Phase 3 Phase 3 data due 2H 2020.
$105.1 billion

GSK – GlaxoSmithKline PLC
Mepolizumab - SYNAPSE
Nasal polyps

Phase 3 Phase 3 data due 1H 2020.
$105.1 billion

GSK – GlaxoSmithKline PLC
Zejula and dostarlimab - MOONSTONE
Ovarian cancer

Phase 2 Phase 2 pivotal data due 2H 2021.
$105.1 billion

NERV – Minerva Neurosciences Inc
Roluperidone (MIN-101)
Schizophrenia

Phase 3 Phase 3 completion of enrolment announced February 5, 2020 with data due 2Q 2020.
$350.8 million

NVO – Novo Nordisk A/S
Semaglutide
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 data due 2Q 2020.
$144 billion

SPRO – Spero Therapeutics Inc.
SPR994 (ADAPT-PO)
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data due 3Q 2020.
$179.1 million

STRO – Sutro Biopharma Inc.
Tebipenem HBr
Healthy Volunteers

Phase 1 Phase 1 trial to be initiated 3Q 2020.
$253.3 million

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-102 SL (Tonmya)
Fibromyalgia

Phase 3 Phase 3 interim analysis due 3Q 2020. Top-line data due 1H 2021.
$5.4 million

TNXP – Tonix Pharmaceuticals Holding Corp.
Tonmya (TNX-102 SL)
Post-traumatic stress disorder (PTSD)

Phase 3 Phase 3 enrolment to be stopped due to futility - February 5, 2020. Top-line data to be reported 2Q 2020.
$5.4 million