The Daily Biotech Pulse: AbbVie In-licenses I-Mab's Cancer Drug, Savara Pulls The Plug On Cystic Fibrosis Study

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 3)

• Akouos Inc AKUS
• FibroGen Inc FGEN(reacted to an adverse clinical readout for a rival drug to treat chronic kidney disease related anemia)
• Generation Bio Co GBIO
• Immunovant Inc IMVT
• Sutro Biopharma Inc STRO ( reacted to announcement concerning presentation of positive data for ovarian cancer drug)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 3)

• Akebia Therapeutics Inc AKBA (announced negative safety results for a late-stage study of drug to treat chronic kidney disease-induced anemia)
• AnPac Bio-Medical Science Co Ltd – ADR ANPC
• Cyclacel Pharmaceuticals Inc CYCC
• Eyepoint Pharmaceuticals Inc EYPT
• Genfit SA GNFT
• Gritstone Oncology Inc GRTS
• Happiness Biotech Group Ltd HAPP
• Homology Medicines Inc FIXX
• Immatics NV IMTX
• Interpace Biosciences Inc IDXG
• Jaguar Health Inc JAGX
• Legend Biotech Corp LEGN
• Monopar Therapeutics Inc MNPR
• NanoVibronix Inc NAOV
• Odonate Therapeutics Inc ODT
• RA Medical Systems Inc RMED
• Recro Pharma Inc REPH
• Rockwell Medical Inc RMTI
• Soliton Inc SOLY
• Sun BioPharma, Inc. SNBP
• Sunesis Pharmaceuticals, Inc. SNSS
• Teligent IncTLGT

Related Link: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates

Stocks In Focus

Lilly Gets FDA Nod For 2 Higher Doses of Its Best-selling Diabetes Drug

Eli Lilly And Co LLY said the FDA approved two additional doses of its Type 2 diabetes drug Trulicity. The approval expands the label of once-weekly Trulicity to include 3 mg and 4.5 mg doses based on data from the AWARD-11 study. The phase 3 trial showed the additional doses led to further benefits in A1C and body weight reduction when compared to Trulicity 1.5 mg, Lilly said.

Trulicity fetched about 22.5% of Lilly's total revenues in the recently reported second quarter and saw growth of 20% year-over-year.

Lilly said the two additional doses will be available in the U.S. in late September.

OraSure's RNA Collection Device Gets EUA To Be Used In COVID-19 Test

OraSure Technologies, Inc. OSUR said its ORAcollect·RNA (OR-100) collection device was included along with other devices in the FDA emergency use authorization, or EUA, granted to MiraDx Inc., a Los Angeles-based molecular genetics company.

MiraDx will utilize the device to collect oropharyngeal samples in its COVID-19 testing program for essential workers and first responders to help prevent the spread of COVID-19, OraSure said.

The stock added 4.57% to $11.21 in after-hours trading.

AbbVie To License I-Mab's Cancer Drug For Up to $1.94B

AbbVie Inc ABBV and I-Mab ADR IMAB said they have signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab, an anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers. In addition, the two partners have the potential to expand the collaboration to additional transformative therapies.

Under the terms of the agreement, AbbVie will pay I-Mab $180 million in an upfront payment to exclusively license lemzoparlimab, along with $20 million in a milestone payment based on the Phase 1 results, for a total of $200 million. In addition, I-Mab will be eligible to receive up to $1.74 billion in success-based milestone payments, of which $840 million are based on clinical development and regulatory approval milestones, with the remainder based on commercial milestones

Separately, I-Mab said it has entered into definitive subscription agreements with a consortium of institutional investors led by Hillhouse Capital to raise approximately $418 million through a private placement.

I-Mab shares were adding 9.73% to $39.25 in pre-market trading, while AbbVie was up 1.23% to $93.

Savara Discontinues Mid-stage Cystic Fibrosis Study Due to COVID-19 and Availability of Rival Drug

Savara Inc SVRA said it has decided to discontinue the ENCORE Phase 2a exploratory study, that is evaluating Molgradex for the treatment of nontuberculous mycobacterial lung infection in people living with cystic fibrosis.

Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor.

The company attributed the decision to discontinue to the impact of COVID-19 on patient recruitment and continued participation in the study as well as the availability of Vertex Pharmaceuticals Incorporated's VRTX new triple-combination CFTR modulator that has become a preferred treatment option for many cystic fibrosis patients.

Savara shares fell 12.41% to $1.20 in after-hours trading.

Roche's Test to Detect SARS-CoV-2 and Influenza A/B Viruses Gets EUA

Roche Holdings AG Basel RHHBY said its cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas 6800/8800 Systems has received EUA from the FDA This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19, Roche said

Puma's Licensing Partner Makes Regulatory Submission Seeking Label Expansion for Breast Cancer Drug

Canadian specialty pharma Knight Therapeutics said it has submitted a supplement to a new drug submission to the Canadian regulatory agency to get a label expansion for Puma Biotechnology Inc's PBYI breast cancer drug Nerlynx. Knight had in-licensed the drug to market it in Canada.

Nerlynx was originally approved in Canada in July 2019 as an extended adjuvant treatment of women with early-stage HER2-overexpressed/amplified breast cancer within one year after completion of Roche's Herceptin-based adjuvant therapy.

The company now seeks to get approval for the drug as a treatment option for metastatic breast cancer.

Earnings

Medical device company Cooper Companies Inc COO reported third-quarter revenues of $578.2 million, down 15% year-over-year, and non-GAAP EPS of $2.28, down 30%. The EPS, however, was ahead of the $1.52-per share consensus estimate.

For the fourth quarter, the company expects non-GAAP EPS of $3 to $3.20 on revenues of $665 million to $693 million. Analysts, on average, estimate EPS of $2.82 on revenues of $661.73 million.

In after-hours trading, the stock added 3.65% to $318.

Offerings

Obseva SA OBSV announced the pricing for its underwritten public offering of common shares, which would fetch the company $20 million in gross proceeds. The company also said a concurrent private placement priced at-the-market of common shares and 15-month purchase warrants would potentially raise an additional $23.9 million.