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AFMD Bleeds On Clinical Hold, BHC Gets FDA Nod, MNLO Disappoints

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Today's Daily Dose brings you news about clinical hold on Affimed's AFM11 phase I program; Altimmune's $25 million registered direct offering; FDA approval of Bausch Health's BRYHALI Lotion; Menlo's disappointing phase II trial results of Serlopitant and Recro Pharma's anticipated make or break event.

Read on...

Shares of Affimed N.V. (AFMD) plunged 25% in extended trading on Monday, following the clinical hold on its AFM11 phase I program.

AFM11 is being evaluated in two phase I clinical studies for the treatment of patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL).

The clinical hold was initiated after the occurrence of Serious Adverse Events (SAEs) in three patients, which included a death in the ALL study and two life-threatening events in the NHL study.

The other clinical programs of the Company namely AFM13 and AMV564 are not affected by the clinical hold.

Near-term Catalysts:

-- A phase Ib combination study of AFM13 with Merck's Keytruda in patients with relapsed/refractory Hodgkin lymphoma is underway.

The interim study data reported in June of this year showed that the combination of AFM13 and Keytruda was well tolerated and had encouraging response rates versus Keytruda monotherapy.

Updated 3- and 6-month results from the study are expected this quarter.

-- An investigator-sponsored translational phase Ib/IIa study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation is ongoing. Results from this study are also expected this quarter.

AFMD closed Monday's trading at $4.63, up 10.77%. In after-hours, the stock was down 25.05% at $3.47.

Shares of Altimmune Inc. (ALT) plunged more than 31% on Monday after the Company entered into a purchase agreement with several institutional investors for the purchase of common units and pre-funded units for a combined total of 4.63 million units in a registered direct offering, for expected gross proceeds of approximately $25 million.

Each common unit is being sold at a public offering price of $5.40 and consists of one share of common stock and a warrant to purchase one share of common stock at an exercise price of $5.40. Each pre-funded unit is being sold at a public offering price of $5.39 and consists of a pre-funded warrant to purchase one share of common stock at an exercise price of $0.01 per share and a warrant to purchase one share of common stock at an exercise price of $5.40.

The offering is expected to close on or about October 10, 2018.

ALT closed Monday's trading at $4.94, down 31.77%.

Bausch Health Companies Inc.'s (BHC) (BHC.TO) BRYHALI Lotion, previously called Jemdel, has secured tentative FDA approval for the treatment of plaque psoriasis in adult patients.

BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate in a novel vehicle lotion.

The final FDA approval for BRYHALI Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch BRYHALI Lotion shortly thereafter, as scheduled, in November 2018.

BHC closed Monday's trading at $26.49, up 0.65%.

Celgene Corp.'s (CELG) blockbuster drug OTEZLA has met the primary end point in a phase III trial in patients with moderate to severe scalp psoriasis.

In the trial, dubbed STYLE, a significantly greater proportion of patients achieved Scalp Physician's Global Assessment response at week 16 with OTEZLA 30 mg twice daily compared with placebo. Statistical significance was also met for the secondary endpoint of the whole body itch numeric rating scale with OTEZLA.

OTEZLA is already approved for the treatment of psoriatic arthritis and plaque psoriasis.

The drug brought home annual sales of $1.28 billion for Celgene in 2017. The Company expects OTEZLA to rake in annual sales of about $1.5 billion in 2018.

CELG closed Monday's trading at $87.49, up 0.25%.

Edwards Lifesciences Corporation (EW) has commenced the U.S. pivotal trial of its self-expanding CENTERA transcatheter valve for severe, symptomatic aortic stenosis patients at intermediate risk of open-heart surgery.

The study is expected to enroll approximately 1,000 patients and has a composite endpoint of all-cause death and/or all stroke at 1 year.

The CENTERA valve was approved in Europe in February 2018 for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis. It is not approved in the U.S.

EW closed Monday's trading at $147.15, down 2.99%.

Mallinckrodt plc.'s (MNK) new drug application for MNK-812, submitted under the 505(b)2 regulatory pathway, is slated to be reviewed by an FDA panel on November 14, 2018.

MNK-812, Mallinckrodt's abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets, is proposed for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The FDA's final decision on MNK-812 is expected on November 16, 2018.

MNK closed Monday's trading at $25.68, down 0.73%.

Shares of Menlo Therapeutics Inc. (MNLO) cratered nearly 40% on Monday on news of the Company's phase II clinical trial of Serlopitant for the treatment of refractory chronic cough failing to demonstrate efficacy relative to placebo on primary and secondary endpoints.

In the study, which had enrolled 185 patients, the Serlopitant group had 31% less reduction than the placebo group in 24-hour cough frequency after 12 weeks of treatment. In a key secondary analysis of response rates, 54% of placebo treated patients and 44% of Serlopitant treated patients experienced a 30% or greater reduction in 24-hour cough frequency at week 12 compared to baseline.

The Company has decided not to continue development of Serlopitant for the treatment of refractory chronic cough.

Menlo has already completed two phase II studies with Serlopitant showing a statistically significant reduction in pruritus compared to placebo.

MNLO closed Monday's trading at $6.14, down 39.57%.

Recro Pharma Inc.'s (REPH) resubmitted New Drug Application for intravenous Meloxicam for the management of moderate to severe pain has been accepted for FDA review, with a decision expected on March 24, 2019.

The FDA had issued a Complete Response Letter for intravenous Meloxicam on May 24, 2018, stating that the analgesic effect did not meet its expectations.

REPH closed Monday's trading at $6.96, down 3.33%.

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