The Daily Biotech Pulse: India Globalization Gets Nod For Alzheimer's Trial, Moderna's Vaccine Deal With US, Cellular Biomedicine To Go Private

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 11)

• Allovir Inc ALVR
• Erytech Pharma SA ERYP
• Eyenovia Inc EYEN (announced an exclusive collaboration and licensing agreement for MicroLine and MicroPine in Greater China and South Korea)
• Evoke Pharma Inc EVOK
• Fortress Biotech FBIO(reacted to its second-quarter results)
• GENMAB A/S/S ADR GMAB
• Inari Medical Inc NARI
• iTeos Therapeutics Inc ITOS
• Kura Oncology Inc KURA
• OncoSec Medical Inc ONCS
• Orthopediatrics Corp KIDS
• Pacira Biosciences Inc PCRX
• Rocket Pharmaceuticals Inc RCKT
• Silk Road Medical Inc SILK
• Trevi Therapeutics Inc TRVI

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 11)

• Burning Rock Biotech Ltd BNR(announced its second-quarter results)
• Homology Medicines Inc FIXX(reacted to its second-quarter results)
• Legend Biotech Corp LEGN
• Nurix Therapeutics Inc NRIX

Stocks In Focus

Moderna Clinches Deal With U.S. Government to Supply 100M Doses of Coronavirus Vaccine For $1.525B

Moderna Inc MRNA said it has negotiated a deal to supply the U.S. government 100 million doses of mRNA-1273, its investigational vaccine against SARS-CoV2, for up to $1.525 billion.

The stock rallied 11.28% to $76.75 in after-hours trading.

India Globalization Gets FDA Approval For Initiating Phase 1 Trial Of CBD Medication In Alzheimer's Patients

India Globalization Capital, Inc. IGC said the FDA notified on July 30 that it has authorized the company to initiate a Phase 1 human trial study for its investigational cannabinoid formulation for the treatment of patients suffering from mild to severe dementia due to Alzheimer's disease.

The company said it plans to begin enrolling patients suffering from Alzheimer's-related dementia for a 12-subject safety Multiple Ascending Dose Study.

The stock soared 73.62% to $1.11 in after-hours trading.

Cellular Biomedicine to Go Private In Transaction Valued at $19.75/Share

Cellular Biomedicine Group Inc CBMG said it has signed a definitive merger agreement to be acquired by a consortium consisting of the company's management, led by CEO Bizuo Liu, which collectively holds about 51.5% of outstanding shares, and private equity investors, for $19.75 in cash for each outstanding share of common stock.

In pre-market trading Wednesday, the stock was jumping 36.30% to $19.45.

Supernus Expects Q2 Revenues to Exceed Consensus

Supernus Pharmaceuticals Inc SUPN announced preliminary second-quarter results, expecting revenues of $126.7 million, up 21% year-over-year. Analysts estimate revenues of $89.34 million.

AzurRx Announces Positive Preliminary Results From Mid-phase Study of Combo Therapy In Cystic Fibrosis

AzurRx BioPharma Inc AZRX announced positive results from the first five patients in its Phase 2 combination therapy trial of MS1819 for the treatment of severe exocrine pancreatic insufficiency in patients with cystic fibrosis.

"In the primary efficacy analysis, patients receiving MS1819 in combination with PERT therapy achieved a clinically meaningful improvement in the coefficient of fat absorption (CFA) at each of the three dose levels, with no adverse safety events reported," AzurRx said.

In after-hours trading, the stock jumped 27.38% to $1.31.

Lilly, Innovent Announce Chinese Regulatory Agency's Acceptance of Application For Tyvyt Label Expansion

Eli Lilly And Co LLY and partner Innovent Biologics said that Chinese drug regulator agency, the National Medical Products Administration, accepted the sNDA for Tyvyt in combination with chemotherapy medication gemcitabine and platinum as first-line therapy in squamous non-small cell lung cancer.

Earnings

Cumberland Pharmaceuticals, Inc. CPIX reported an increase in second-quarter net revenues from $9.4 million in 2019 to $9.6 million in 2020. Adjusted earnings per share, or EPS, increased from 5 cents to 8 cents, while analysts had estimated EPS of 3 cents.

The stock gained 7.99% to $3.65 in after-hours trading.

Inari Medical's second-quarter revenues fell from $27 million in 2019 to $25.4 million in 2020. The net loss per share narrowed from 17 cents to 16 cents, while analysts estimated a loss of 18 cents per share.

The stock rose 6.07% to $65.90 in after-hours trading.

T2 Biosystems Inc TTOO said its second-quarter revenues increased from $1.80 million in 2019 to $2.55 million in 2020. The loss per share narrowed from 35 cents to 9 cents, while analysts estimated a loss per share of 15 cents.

The company guided full-year revenues to $18 million-$20 million, with 60 T2Dx Instrument sales contracts expected to be received in the year. Analysts, on average, estimate revenues of $14.55 million.

The stock was down 11.23% to $1.66.

Offerings

Pacific Biosciences of California Inc PACB said it priced its previously announced underwritten public offering of 19.43 million shares of its common stock at $4.47 per share, for raising gross proceeds of about $86.9 million. The offering is expected to close on or about August 14, 2020 subject to satisfaction of customary closing conditions.

The stock added 1.79% to $4.55 in after-hours trading.

Seres Therapeutics Inc MCRB said it is commencing an underwritten registered public offering of 8 million shares of its common stock. All of the shares in the proposed offering are to be sold by the company.

The stock moved up 0.80% to $20.20 in after-hours trading.

Adverum Biotechnologies Inc ADVM said it has commenced an underwritten public offering of $200 million worth of its common stock.

In after-hours trading, the stock was down 3.40% to $15.06.

Trevena Inc TRVN said it intends to offer shares of its common stock in an underwritten public offering.

The stock slumped 16.79% to $2.28 in after-hours trading.

On The Radar

Earnings

Royalty Pharma plc RPRX (before the market open)
Beam Therapeutics Inc BEAM (before the market open)
Trillium Therapeutics Inc TRIL (before the market open)
Milestone Pharmaceuticals Inc MIST (before the market open)
Ideaya Biosciences Inc IDYA (before the market open)
TELA Bio Inc TELA (after the market close)
Brickell Biotech Inc BBI (after the market close)
Dare Bioscience Inc DARE (after the market close)
Biocept Inc BIOC (after the market close)
ImmuCell Corporation ICCC (after the market close)
Eyenovia Inc EYEN (after the market close)
Eton Pharmaceuticals Inc ETON (after the market close)
Thermogenesis Holdings Inc THMO (after the market close)
OpGen Inc OPGN (after the market close)
KemPharm Inc KMPH (after the market close)
Neoleukin Therapeutics Inc NLTX (after the market close)
Salarius Pharmaceuticals Inc SLRX (after the market close)