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Wednesday, June 26, 2019

Bayer seeks outside litigation on Roundup; Elliott reveals stake

Bayer (OTCPK:BAYRY +4.3%) says it has hired an external lawyer to advise its supervisory board and formed a new committee in an attempt to resolve the company’s multi-billion dollar glyphosate litigation problem.
Taking the job is U.S. lawyer John Beisner from Skadden, Arps, Slate Meagher & Flom LLP to advise the supervisory board on matters related to the glyphosate litigations, including trial tactics and mediation.
More than 13K plaintiffs in the U.S. allege Bayer’s glyphosate weedkiller Roundup, produced by Monsanto, caused cancer and that the company failed to warn about risks in using the product.
Elliott Associates discloses it holds Bayer shares and financial instruments equivalent valued at 1.1B ($1.3B) and says the company’s steps today will provide a new level of oversight and a fresh perspective to a litigation strategy, which it says needs a radical overhaul.

Pfizer in red as CDC advisory panel reviews Prevnar 13 patient populations


The broad selloff in the healthcare sector notwithstanding, Pfizer (PFE-2.3%) is under additional pressure, albeit modest, in apparent reaction to a two-day meeting at the CDC Atlanta.
The Advisory Committee on Immunization Practices (ACIP) is discussing immunization practices for a range of vaccines, including HPV, pneumococcus, measles, rabies, pertussis, diptheria and tetanus.
Investors seem wary that the committee may vote to modify the targeted patient population for the company’s pneumococcal vaccine PREVNAR 13. The specific population that may be amended appears to be adults over the age of 65.
Update: The committee voted to revise the pneumococcal vaccination guidelines for adults aged 65+ based on “shared clinical decision-making” between the patients and healthcare provider. In other words, the vaccination decision should be made on an individual basis based on mutual agreement.

CDC advisory group backs HPV catch-up vaccination

In a unanimous vote, the CDC’s Advisory Committee on Immunization Practices backs catch-up vaccination against human papillomavirus (HPV) infection in adults over the age of 26.
The news may modestly boost demand for Merck’s (MRK -1.8%Gardasil 9(human papillomavirus 9-valent vaccine, recombinant) since it is currently approved for people ages 9 – 45.

Magellan Health in sale talks; shares up 9%

The WSJ reports that private equity shop Centerbridge Partners LP is in exclusive negotiations with Magellan Health (MGLN +8.5%) about a possible sale. Informed sources say a deal could be reached next month.

Verrica’s VP-102 shows positive effect in mid-stage study

Verrica Pharmaceuticals (NASDAQ:VRCAannounces positive results from an open-label Phase 2 clinical trial, COVE-1, evaluating VP-102 for the treatment of verruca vulgaris (common warts).
51% (n=18/35) of patients in Cohort 2 treated with VP-102, a 0.7% solution of cantharidin, showed complete clearance of all warts at day 84.
On the safety front, VP-102 was well-tolerated with no serious adverse events observed.
The company plans to request an end-of-Phase 2 meeting with the FDA to clarify a registration path. It plans to file a U.S. marketing application later this year for molluscum contagiosum.
Management will host a conference call tomorrow, June 27, at 8:00 am ET to discuss the results.
Shares are up 6% after hours.

Aclaris’ ATI-502 flunks mid-stage alopecia study

Aclaris Therapeutics (NASDAQ:ACRS) is set for a significant down move on the heels of a failed Phase 2 clinical trial evaluating ATI-502 in patients with an autoimmune disorder characterized by hair loss called alopecia areata.
The study did not meet the primary or secondary endpoints due to high rates of disease resolution in the vehicle (placebo) arm.
Management will host a conference call at 5:00 pm ET to discuss the results.
Shares will resume trading at 4:30 pm ET.

Rite Aid Q1 revenue in-line

Rite Aid (NYSE:RAD): Q1 Non-GAAP EPS of -$0.14 beats by $0.79; GAAP EPS of -$1.88 misses by $0.95.
Revenue of $5.37B (-0.4% Y/Y) in-line.
Shares -5.6%.