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Thursday, March 12, 2020

Mallinckrodt up 11% premarket on potential of iNO in COVID-19

Mallinckrodt (NYSE:MNK) bucks the broad market’s bearishness, up 11% premarket, albeit on modest volume.
This morning, it announced that it’s evaluating “limited published evidence” that inhaled nitric oxide (iNO), marketed as INOmax, may be useful as a supportive measure in COVID-19 patients with pulmonary complications.
It has engaged the FDA, NIH and BARDA on the matter, but cautions that the safety and efficacy of iNO for this use has not been established.
On the opioid settlement front, it reports that it has inked agreements with certain lenders and debt holders for a new $690M term loan, the proceeds of which will be used to redeem $615M of unsecured notes due 2020. It has also agreed to modify its existing credit agreement, increasing the interest rate by 1.0%, a step-up in amortization and the payment of a one-time 0.5% fee to lenders.
The $1.6B settlement will be paid as follows: $300M at closing, $200M on the first and second anniversary of closing and $150M on the third through the eighth anniversary of closing (reported yesterday). The previously announced issuance of warrants also remains unchanged.
https://seekingalpha.com/news/3550963-mallinckrodt-up-11-premarket-on-potential-of-ino-in-covidminus-19

Analyst action, March 12

Allakos (NASDAQ:ALLK) initiated with Underperform rating and $34 (42% downside risk) price target at SMBC Nikko.
Avadel Pharmaceuticals (NASDAQ:AVDL) initiated with Buy rating and $14 (75% upside) price target at Stifel.
Krystal Biotech (NASDAQ:KRYS) initiated with Outperform rating and $73 (46% upside) price target at SMBC Nikko.
Momenta Pharmaceuticals (NASDAQ:MNTA) initiated with Neutral rating and $29 (10% upside) price target at Goldman Sachs.
Scholar Rock Holding (NASDAQ:SRRK) initiated with Outperform rating and $35 (136% upside) price target at Baird.
Jazz Pharmaceuticals (NASDAQ:JAZZ) upgraded to Outperform with a $166 (54% upside) price target at Bernstein.
Mirati Therapeutics (NASDAQ:MRTX) upgraded to Neutral with an $88 (14% upside) price target at JPMorgan.
Vanda Pharmaceuticals (NASDAQ:VNDA) upgraded to Buy with a $14 (32% upside) price target at Citigroup.
Teladoc (NYSE:TDOC) downgraded to Neutral with a $130 (5% downside risk) price target at Baird. Shares down 8% premarket.
https://seekingalpha.com/news/3550984-baird-cuts-view-on-teladoc-in-premarket-analyst-action

Lilly’s Jardiance Fast Track’d for CV benefit in kidney disease

The FDA has designated Eli Lilly’s (NYSE:LLY) type 2 diabetes (T2D) med Jardiance (empagliflozin) for Fast Track review to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Jardiance was approved in the U.S. in August 2014 for the treatment of T2D and in December 2016 to reduce CV death in adults with T2D.
Shares down 5% premarket on light volume due to the COVID-19 selloff.
https://seekingalpha.com/news/3550995-lillys-jardiance-fast-trackd-for-cv-benefit-in-kidney-disease-patients

Twist Bio releases new coronavirus control

Twist Bioscience (NASDAQ:TWST) announces the availability of two synthetic SARS-CoV-2 RNA controls for use in developing, verifying and validating diagnostic tests for COVID-19, including next-gen sequencing and reverse transcription-polymerase chain reaction assays.
Controls are routinely used with tests to monitor variability (within-run and day-to-day) and quality measures.
https://seekingalpha.com/news/3551001-twist-bio-releases-new-coronavirus-controls

Vir Biotech up 27% premarket on COVID-19 deal with Biogen

Vir Biotechnology (NASDAQ:VIR) has signed a letter of intent with Biogen (NASDAQ:BIIB) for the development and clinical manufacturing of human monoclonal antibodies for the potential treatment of COVID-19.
Due to the present level of urgency, work has begun while a formal agreement is being negotiated. Contingent on the consummation of the deal, Biogen will continue cell line development, process development and clinical manufacturing aimed at advancing Vir’s proprietary antibodies.
Vir says it has identified “a number” of monoclonals that bind to SARS-CoV-2 that have been isolated from people who survived a SARS infection.
VIR is up 27% premarket while BIIB is down 5%, both on light volume.
https://seekingalpha.com/news/3551009-vir-biotech-up-27-premarket-on-covidminus-19-deal-biogen

Axsome Therapeutics down 17% premarket on Q4 results

Axsome Therapeutics (AXSM) Q4 results: Revenues: $0; Net loss: ($24.8M) (-158.3%); loss/share: ($0.71) (-121.9%); Quick Assets: $220M.
Anticipated Milestones: NDA filings for AXS-05 in the treatment of MDD and AXS-07 for the treatment of migraine in Q4.
Topline results for Phase 3 STRIDE-1 trial of AXS-05 in TRD and Phase 3 INTERCEPT trial of AXS-07 in migraine on track for Q1.
Topline results for ADVANCE Phase 2/3 trial of AXS-05 in Alzheimer’s disease agitation anticipated in Q3.
Initiation of Phase 3 trial of AXS-12 in narcolepsy anticipated in H2.
Axsome plans to meet with the FDA in 2020 to discuss the further clinical development of AXS-14 for the treatment of fibromyalgia.
Shares are down 17% premarket.
https://seekingalpha.com/news/3551012-axsome-therapeutics-down-17-premarket-on-q4-results

Inovio up 19% premarket on Gates grant to support COVID-19 vaccine

The Bill & Melinda Gates Foundation has awarded a $5M grant to Inovio Pharmaceuticals (NASDAQ:INO) to accelerate the testing and scale-up of the Cellectra 3PSP smart device for the intradermal delivery of INO-4800, its potential DNA vaccine for COVID-19.
The company plans to launch a Phase 1 study next month enabled by up to $9M in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
Cellectra 3PSP is a small, portable, hand-held, battery-operated device that is designed to administer vaccines and therapies.
Inovio says its goal is to deliver 1M doses of INO-4800 and the requisite number of Cellectra devices by year-end.
https://seekingalpha.com/news/3551022-inovio-up-19-premarket-on-gates-grant-to-support-covidminus-19-vaccine