BPC June 16 update

Steroid becomes first treatment showing mortality benefit for COVID; Ideaya IDYA deal with Glaxo GSK +43%

Price and Volume Movers

Researchers at Oxford University announced that a low-cost steroid called dexamethasone reduced death by up to one third in hospitalised patients with severe respiratory complications of COVID-19, making it the first drug that has shown to significantly improve mortality in COVID patients. A total of 2104 patients were randomized to receive dexamethasone compared with 4321 patients randomized to usual care alone. Dexamethasone reduced deaths by one-third in ventilated patients (rate ratio 0.65; p=0.0003) and by one fifth in other patients receiving oxygen only (0.80; p=0.0021). There was no benefit among those patients who did not require respiratory support (1.22; p=0.14). Based on these results, 1 death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone.

Eli Lilly and Company (NYSE: LLY) announced that its Phase 3 trial of Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET), met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. Shares closed up 16% to $163.71

Ideaya Biosciences, Inc. (Nasdaq: IDYA) shares closed up 43% to $12.84 on news of a partnership with GlaxoSmithKline plc (NYSE:GSK) for its Synthetic Lethality programs MAT2A, Pol Theta, and Werner Helicase programs, which are projected to reach clinical trials within the next three years. Ideaya will receive a $100m upfront cash payment, and a $20m equity purchase of its common stock in a direct private placement, and a potential $50m cash option exercise fee for the MAT2A program. Ideaya is also entitled to receive potential preclinical, clinical and sales milestones and will receive a 50% US profit share for the MAT2A and Werner Helicase programs.

Amarin Corporation plc (NASDAQ:AMRN) shares are trading up 5% to $7.22 after hours on news of a settlement agreement with Apotex Inc. that resolves patent litigation that would have resulted from an abbreviated new drug application (ANDA) filed by Apotex seeking approval of a generic form of Vascepa. As part of the settlement agreement, Apotex may not sell a generic version of Vascepa in the United States until August 9, 2029.

Neurocrine Biosciences, Inc. (Nasdaq:NBIX) and Takeda Pharmaceutical Company Limited (NYSE:TAK) announced a collaboration to develop and commercialize compounds in Takeda’s early-to-mid-stage psychiatry pipeline. Takeda granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including three clinical stage assets for schizophrenia, treatment-resistant depression and anhedonia, which are all listed in the pipeline update table below. Takeda will receive a total of $120m in upfront cash and will be entitled to development milestones of up to $495m, commercial milestones of up to $1.4b and up to double-digit royalties on net sales.

Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) shares are trading down 23% to $0.44 on news that it intends to offer and sell shares of its common stock in a public offering.

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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:

Celsion Corporation (CLSN): $4.88; +33%.

Annovis Bio, Inc. (ANVS): $5.64; +26.

Xeris Pharmaceuticals, Inc. (XERS): $5.32; +18%.

Amicus Therapeutics, Inc. (FOLD): $13.07; +17%.

Monopar Therapeutics Inc. (MNPR): $9.50; +16%.

DECLINERS:

AVEO Pharmaceuticals, Inc. (AVEO): $6.25; -19%.

BioCardia, Inc. (BCDA): $2.90; -16%.

Generation Bio Co. (GBIO): $20.10; -12%.

MediciNova, Inc. (MNOV): $5.70; -10%.

Brickell Biotech, Inc. (BBI): $1.70; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AVXL – Anavex Life Sciences Corp.
ANAVEX 2-73 - U.S. RS-001
Rett syndrome

Phase 2 Phase 2 top-line data due 2H 2020.
$290.4 million

LLY – Eli Lilly and Company
Abemaciclib - monarchE
HR+ / HER2- breast cancer

Phase 3 Phase 3 trial met the primary endpoint of invasive disease-free survival (IDFS) - June 16, 2020.
$156.7 billion

NBIX – Neurocrine Biosciences Inc.
TAK-831
Negative symptoms of schizophrenia

Phase 2 Phase 2 trial is ongoing.
$11.6 billion

NBIX – Neurocrine Biosciences Inc.
TAK-653
Treatment-resistant depression

Phase 2 Phase 2 trial planned.
$11.6 billion

NBIX – Neurocrine Biosciences Inc.
TAK-041
Anhedonia in depression

Phase 2 Phase 2 trial planned.
$11.6 billion

SAVA – Cassava Sciences Inc.
PTI-125
Alzheimer’s disease

Phase 2b Phase 2b trial did not meet primary endpoint - May 15, 2020. Detailed data due 3Q 2020.
$70.9 million

SNY – Sanofi
Avalglucosidase alfa (NeoGAA) - COMET
Pompe disease

Phase 3 Phase 3 data presented June 16, 2020 met the primary endpoint demonstrating non-inferiority in improving respiratory function compared to alglucosidase alfa (standard of care) but not superiority.
$129.7 billion