BPC November 11 update

Liquidia LQDA +22% Insider buys; Compugen CGEN +14% Deal with BMY

Price and Volume Movers

Liquidia Corporation (NASDAQ: LQDA) General Counsel Russell Schundler acquired a total of 117908 shares at an average price of $4.21. The insider spent $496,834.09. Shares closed up 22% at $5.17.

Compugen Ltd. (NASDAQ: CGEN) announced that Bristol Myers Squibb (NYSE: BMY) completed its $20 million investment in Compugen in consideration for the issuance of 2,332,815 shares of Compugen purchased at $8.57333 per share, representing a 33% premium over the closing price on November 9, 2021. Shares closed up 14% at $7.16.

Cortexyme, Inc. (NASDAQ: CRTX) presented additional data from its Phase 2/3 GAIN trial of atuzaginstat to treat Alzheimer’s disease. Data noted that the 40 mg dose reported better efficacy compared to 80 mg, with benefits shown in ADAS-Cog11, CDR-SB, MMSE, and NPI. However, benefits were not seen on ADCS-ADL at either dose. Shares closed down 7% at $14.57.

Raymond James upgrades ADMA Biologics Inc (NASDAQ: ADMA) shares to Strong Buy, with a $5 price target. ADMA also beat the consensus estimate of $18.72 million for quarterly sales, reporting $20.7 million, an 101% increase over the same period last year. Shares closed up 14% at $1.59.

Notable earnings releases from today:

TherapeuticsMD, Inc. (NASDAQ: TXMD)

Virios Therapeutics, Inc. (NASDAQ: VIRI)

MorphoSys AG (NASDAQ: MOR)

Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT)

Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM)

Advancers

CompanyPriceChange
BFRI
Biofrontera Inc.
$7.90+2.68  +51.34%
NRXP
NRX Pharmaceuticals Inc.
$6.75+2.25  +50.00%
ADGI
Adagio Therapeutics Inc.
$25.12+6.39  +34.12%
ATNF
180 Life Sciences Corp.
$5.41+0.95  +21.30%
GOVX
GeoVax Labs Inc.
$4.69+0.81  +20.88%
MRNA
Moderna Inc.
$329.63+56.24  +20.57%
ICVX
Icosavax Inc.
$27.55+4.51  +19.57%
VALN
Valneva SE
$59.60+9.7  +19.44%
TYRA
Tyra Biosciences Inc.
$23.87+3.66  +18.11%
PTPI
Petros Pharmaceuticals Inc.
$2.09+0.26  +14.21%

Decliners

CompanyPriceChange
LGVN
Longeveron Inc.
$30.67-11.63  -27.49%
AMTI
Applied Molecular Transport Inc.
$16.33-2.66  -14.01%
NEXI
NexImmune Inc.
$7.94-1.06  -11.78%
IGMS
IGM Biosciences Inc.
$49.63-6.58  -11.71%
CRNX
Crinetics Pharmaceuticals Inc.
$24.40-3.08  -11.21%
AVRO
AVROBIO Inc.
$4.08-0.51  -11.11%
ELYM
Eliem Therapeutics Inc
$13.76-1.72  -11.11%
MRSN
Mersana Therapeutics Inc.
$6.95-0.82  -10.55%
MNOV
MediciNova Inc.
$3.22-0.35  -9.80%
TARS
Tarsus Pharmaceuticals Inc.
$25.00-2.7  -9.75%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ACER – Acer Therapeutics Inc.
ACER-001
Urea cycle disorder (UCD)

$2.20
-0.06  -3%
PDUFA PDUFA date June 5, 2022.
$31.5 million

ADAP – Adaptimmune Therapeutics plc
Afami-cel - (SPEARHEAD‑1)
Synovial sarcoma or myxoid/round cell liposarcoma (MRCLS)

$4.07
-0.21  -5%
Phase 2 Phase 2 initial data at ASCO June 4-8, 2021. Abstract noted overall response rate was 39.3% (13/33), 41.4% (12/29) for synovial sarcoma; 25.0% (1/4) for MRCLS. Phase 2 trial expected to meet primary endpoint at final analyst later this year. Data reported an Independent Review overall response rate of 34% with 16 of 47 patients with partial responses (PR). The overall response rate was 36% in patients with synovial sarcoma, and 25% for patients with MRCLS, noted November 11, 2021. BLA filing due in 2022.
$635.8 million

ALKS – Alkermes plc
ALKS 1140
Healthy Subjects

$22.47
-0.41  -2%
Phase 1 Phase 1 trial initiated in October 2021, first subjected dosed November 11, 2021.
$3.6 billion

ALXO – ALX Oncology Holdings Inc.
ALX148 and HERCEPTIN (Trastuzumab) - (ASPEN-01)
Solid Tumors and Lymphoma

$33.59
-2.73  -8%
Phase 1 Phase 1 initial data suggest evorpacept is well tolerated with no DLTs in combination with the antibody/cytotoxic chemotherapy regimens evaluated above and a MAD of 15 mg/kg QW. Consistent with standard CPI therapeutic agents, the initial response benefit seen with evorpacept in combination is notably magnified in longer term PFS and OS endpoints in both the HNSCC and GC populations, noted November 9, 2021.
$1.4 billion

APTO – Aptose Biosciences Inc.
Luxeptinib (CG-806)
Chronic lymphocytic leukemia (CLL/SLL) or non-Hodgkin lymphomas (NHL)

$2.28
-0.12  -5%
Phase 1 Phase 1 updated data at EHA June 11, 2021, tumor reduction in patient with follicular lymphoma (FL) upon dose escalation from 750 mg to 900 mg. Additional data to be presented at ASH December 11, 2021.
$202.8 million

BIIB – Biogen Inc.
BAN2401 (lecanemab)
Alzheimer’s disease

$242.90
-7.23  -3%
BLA Filing BLA rolling submission initiated September 28, 2021. Phase 2b data noted that the ED90 dose achieved a ≥90% probability of ≥25% reduction compared to the primary endpoint of 80% probability of ≥25% reduction in decline versus placebo, noted November 11, 2021.
$35.7 billion

CRTX – Cortexyme Inc.
Atuzaginstat - GAIN
Alzheimer’s disease

$12.03
-0.19  -2%
Phase 2/3 Phase 2/3 top-line data reported that the trial did not meet its co-primary endpoints, noted October 26, 2021. Phase 2/3 data reported that the 40 mg demonstrated equivalent or better efficacy compared 80 mg, as well as a superior safety profile. Benefits were shown in ADAS-Cog11, CDR-SB, MMSE, and NPI, with increasing separation from placebo throughout the study consistent with disease modification. Benefits were not seen on ADCS-ADL at either dose, noted November 11, 2021.
$359.4 million

GRAY – Graybug Vision Inc.
GB-102 (ALTISSIMO)
Wet age-related macular degeneration

$2.70
-0.09  -3%
Phase 2b Phase 2b data released March 9, 2021. BCVA approx 9 letters lower across all time points than that observed in the control (aflibercept) arm. Extension trial top-line data noted 55% of patients maintained visual acuity and central retinal thickness. In addition, the injection burden was reduced by 73%, noted September 28, 2021. Additional Phase 2b data reported that the anatomical control was similar to aflibercept over 18 months with BCVA maintained in extension study, noted November 15, 2021.
$57.6 million

LLY – Eli Lilly and Company
JARDIANCE (empagliflozin)
Heart failure with preserved Ejection Fraction (HFpEF)

$260.37
-1.63  -1%
PDUFA priority review PDUFA priority review in May 2022.
$249.1 billion

MTCR – Metacrine Inc.
MET409 with JARDIANCE (empagliflozin)
Type 2 Diabetes and Nonalcoholic steatohepatitis (NASH)

$1.31
-0.04  -3%
Phase 2a Phase 2a top-line data released November 2, 2021. All regimens had favorable safety profiles and were generally well-tolerated, with no treatment-related serious adverse events (AEs). Mild-moderate pruritus was reported in 0%-6% of patients across all groups.
$35.8 million

RFL – Rafael Holdings Inc. Class B
CPI-613 (devimistat) + hydroxychloroquine - (APOLLO 613)
Clear cell sarcoma

$5.90
-0.36  -6%
Phase 1/2 Phase 1/2 first patient enrolled noted November 11, 2021.
$121.9 million

RNXT – RenovoRx Inc.
RenovoGem (TIGeR-PaC)
Locally advanced pancreatic cancer (LAPC)

$6.39
-0.02  0%
Phase 3 Phase 3 initial data reported an increased survival benefit from RenovoTAMP with a median overall survival of 23.1 months. In addition, treatment via the superior mesenteric artery (SMA) delivered greatest survival benefits, with median overall survival of 31.7 months when compared with treatment via other arteries, noted November 11, 2021.
$56.9 million

RPHM – Reneo Pharmaceuticals Inc.
REN001-102
Long-chain fatty acid oxidation disorders (LC-FAOD)

$7.03
-0.69  -9%
Phase 1b Phase 1b enrollment completed noted November 11, 2021. Phase 1b data due 2Q 2022.
$171.7 million