BPC September 30 update

Alzamend ALZN +35% FDA response to Pre-IND; MRK acquisition XLRN

Price and Volume Movers

Alzamend Neuro, Inc. (NASDAQ: ALZN) announced that it has received a written response from the FDA to its meeting request relating to its Type B Pre‑Investigational New Drug (IND) application for AL002 to treat Alzheimer's Disease. Alzamend anticipates filing an IND by the end of November 2021 and initiating the clinical trial of AL002 in the first quarter of 2022. Shares closed up +35% at $3.08.

Merck (NYSE: MRK) and Acceleron Pharma Inc. (NASDAQ: XLRN) announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Acceleron for an approximate $11.5 billion. Merck's acquisition subsidiary will merge into Acceleron. The remaining Acceleron stock will be canceled and converted into the right to receive $180 per share. The transaction will close in the fourth quarter of 2021.

Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) announced data from its DERMIS-1 and DERMIS-2 Phase 3 studies of roflumilast cream reduced itch in chronic plaque psoriasis. In addition, in two separate Phase 2 studies, topical roflumilast foam reduced itch in the scalp, body psoriasis, and seborrheic dermatitis. In these studies, both roflumilast cream and roflumilast foam met their primary endpoints. Shares closed up 6% at $23.89.

Kite, a Gilead Company (NASDAQ: GILD), announced it submitted a supplemental Biologics License Application (sBLA) to the FDA for Yescarta (axicabtagene ciloleucel) to treat large B-cell lymphoma.

Advancers

CompanyPriceChange
PROG
Progenity Inc.
$3.07+0.57  +22.80%
CNTX
Context Therapeutics Inc.
$6.99+0.82  +13.29%
ATHA
Athira Pharma Inc.
$10.75+1.12  +11.63%
RPTX
Repare Therapeutics Inc.
$24.66+1.9  +8.35%
EYEN
Eyenovia Inc.
$6.41+0.44  +7.33%
TYRA
Tyra Biosciences Inc.
$23.01+1.54  +7.17%
CMPS
COMPASS Pathways Plc
$37.81+2.5  +7.09%
KALA
Kala Pharmaceuticals Inc.
$2.03+0.13  +6.84%
PTPI
Petros Pharmaceuticals Inc.
$1.82+0.12  +6.79%
MRTX
Mirati Therapeutics Inc.
$187.52+10.22  +5.76%

Decliners

CompanyPriceChange
MTCR
Metacrine Inc.
$1.66-2.17  -56.79%
OCUL
Ocular Therapeutix Inc.
$6.88-3.95  -36.48%
AGEN
Agenus Inc.
$3.88-1.25  -24.27%
SIOX
Sio Gene Therapies Inc.
$2.02-0.34  -14.41%
STAB
Statera Biopharma Inc.
$3.32-0.55  -14.21%
JANX
Janux Therapeutics Inc.
$22.03-2.99  -11.95%
RNLX
Renalytix AI plc
$24.14-3.26  -11.90%
GRCL
Gracell Biotechnologies Inc.
$10.33-1.39  -11.86%
APLT
Applied Therapeutics Inc.
$13.87-1.82  -11.60%
XFOR
X4 Pharmaceuticals Inc.
$4.43-0.52  -10.51%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ARQT – Arcutis Biotherapeutics Inc.
Roflumilast Cream (ARQ-151) - DERMIS-2
Plaque psoriasis

$21.44
-0.34  -2%
Phase 3 Phase 3 data met its primary endpoint of Investigator Global Assessment Success rate at week 8 in 37.5% compared to a vehicle rate of 6.9%, noted September 30, 2021.
$1.1 billion

ASND – Ascendis Pharma A/S
TransCon - PaTHway
Hypoparathyroidism

$143.00
-2.62  -2%
Phase 3 Phase 3 top-line data due 1Q 2022.
$8.1 billion

BCYC – Bicycle Therapeutics plc
BT5528 and OPDIVO (nivolumab)
Solid tumors

$54.97
-1.33  -2%
Phase 1/2 Phase 1 interim results from Phase 1/2 trial demonstrated anti-tumor activity observed in late line patients, with 2 partial responses out of 2 urothelial cancer patients dosed and an 80% disease control rate in ovarian cancer patients, including 1 partial response. A recommended BT5528 Phase 2 dose (RP2D) range has been established at 6.5-8.5mg/m2 every other week, a dose that is believed to be within the therapeutic range based on both preclinical studies and preliminary clinical anti-tumor activity. - noted October 7, 2021. Expansion cohorts expected to initiate in 2022.
$1.6 billion

BHC – Bausch Health Companies Inc.
Perfluorohexyloctane (NOV03) (MOJAVE)
Dry Eye Disease Associated With Meibomian Gland Dysfunction

$28.59
0.00  0%
NDA Filing Phase 3 trial met primary and secondary endpoints, noted September 30, 2021. NDA filing due 2022.
$10.3 billion

EQ – Equillium Inc.
Itolizumab (EQ001) - (EQUALISE)
Systemic lupus erythematosus (SLE) and lupus nephritis (LN)

$5.68
-0.35  -6%
Phase 1b Phase 1b top-line data from Type A patients (SLE) released March 30, 2021 - safe and well tolerated. Phase 1b interim safety results to be presented in at the American Society of Nephrology (ASN) Annual Meeting to be held November 4-7, 2021. Type B data (lupus nephritis) due 2H 2021.
$166.9 million

GILD – Gilead Sciences Inc.
YESCARTA (ZUMA-7)
Refractory diffuse large B-cell lymphoma (DLBCL)

$66.81
-0.17  0%
BLA Filing sBLA submission September 30, 2021.
$83.8 billion

INCY – Incyte Corporation
OLUMIANT (baricitinib)
Alopecia Areata

$65.86
-0.01  0%
NDA Filing Phase 3 trial met primary endpoint - April 19, 2021. Phase 3 data displayed statistically significant improvement occurring in the 4-mg dosing at 24 weeks with more than 1 in 4 patients reaching 80% or more scalp hair coverage as compared to placebo, and 1 in 10 achieved 80% or more in the 2-mg dose, noted September 30, 2021. NDA filing due 2H 2021.
$14.5 billion

NERV – Minerva Neurosciences Inc
Roluperidone (MIN-101)
Schizophrenia

$1.25
-0.04  -3%
Phase 3 Phase 3 results met all key pharmacokinetic (PK) objectives and the data demonstrate bioequivalence across the various formulations - noted September 30, 2021.
$53.6 million

ORIC – Oric Pharmaceuticals Inc.
ORIC-101 and XTANDI (Enzalutamide)
Prostate cancer

$14.93
-0.18  -1%
Phase 1b Phase 1b initial results showed that the dose was well tolerated, with no substantial added toxicity. PK showed no evidence of drug-drug interaction. Within the key patient population (8), 75% of patients' tumors expressed moderate to high GR and 25% of patients' tumors expressed low GR, noted October 7, 2021.
$587 million

PSTV – PLUS THERAPEUTICS Inc.
Rhenium-186 NanoLiposome ( 186 RNL) - (ReSPECT)
Glioblastoma

$1.66
-0.07  -4%
Phase 1 Phase 1 data presented August 21, 2021. Treatment was well tolerated, with no dose-limiting toxicity or serious adverse events observed. Phase 1 interim data to be presented November 19, 2021. Phase 2/3 study to be initiated mid-2022.
$25.4 million

RETA – Reata Pharmaceuticals Inc.
Omaveloxolone
Friedreich’s ataxia (FA)

$96.45
-2.35  -2%
NDA Filing NDA filing planned for 1Q 2022.
$3.5 billion

RPTX – Repare Therapeutics Inc.
RP-3500 (TRESR)
Solid tumors

$24.66
+1.90  +8%
Phase 1/2 Phase 1/2 dosing of first patient announced July 29, 2020. Phase 1/2 data noted treatment appears safe and well tolerated. Clinical benefit was observed in 49% of 69 patients, including 12 patients with tumor responses per established international efficacy criteria, 14 reported stable disease (SD) for 16 weeks and 8 patients with SD who only had two radiological evaluations, but had demonstrated significant decreases in tumor markers and tumor shrinkage of less than 30%, noted October 8, 2021.
$915.3 million

TGTX – TG Therapeutics Inc.
Ublituximab - ULTIMATE I
Multiple Sclerosis

$31.05
-0.76  -2%
BLA Filing BLA submitted September 30, 2021. The primary endpoint met resulted in an ARR of 0.076 compared to 0.188 for teriflunomide, representing a relative reduction of approximately 60% (p<0.0001), 44.6% of treated patients achieved NEDA representing a 198% improvement and MRI results showed a total number of T1 Gadolinium (Gd) enhancing lesions were reduced as a result of treatment by 97%. The dose was generally well tolerated with no unexpected safety signals, noted October 14, 2021
$4.4 billion

TPTX – Turning Point Therapeutics Inc.
Repotrectinib (TPX-0005) - TRIDENT-1
Non-small-cell lung cancer (NSCLC) and solid tumors

$42.87
-1.37  -3%
Phase 1/2 Phase 2 updated data from the Phase 1/2 trial noted in the population treated with one prior TKI and prior platinum-based chemotherapy the cORR was 39%. In populations with two prior TKIs without prior chemotherapy cORR was 30%. In populations with one prior TKI without prior chemotherapy the cORR was 38%. Dose modifications due to TEAEs included 27% of patients who had dose reduction and 11% who had drug discontinuation, noted October 7, 2021. Phase 2 date noted a confirmed ORR of 48% in patients with NTRK+ TKI-pretreated advanced solid tumors, 62% in NTRK+ TKI-pretreated advanced solid tumor patients with solvent front mutations and 41% in patients with NTRK+ TKI-naive advanced solid tumors, noted October 8, 2021. Breakthrough Therapy Designation announced October 4, 2021.
$2.1 billion